Urinary Bladder, Neurogenic
Conditions
Keywords
neurogenic detrusor overactivity, neurogenic bladder, neuropathic bladder, neurologic disease, fesoterodine
Brief summary
The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.
Interventions
Fesoterodine 4 mg tablet once daily for 24 weeks
Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
DRUGOxybutynin
Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.
DRUGFesoterodine PR
Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 6 to 17 years old * Subjects with stable neurological disease and neurogenic detrusor overactivity * Subjects using clean intermittent catheterization may participate
Exclusion criteria
* Concomitant medications which may increase the risk to subjects or confound study results * Other medical conditions which may increase the risk to subjects or confound study results * Contraindications to the use of fesoterodine or oxybutynin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12. |
| Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | Bladder volume (in milliliter) at first IDC was measured using urodynamic testing. |
| Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 micturitions at Baseline. |
| Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 catheterizations at Baseline. |
| Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline. |
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 incontinence episodes at Baseline. |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with \>0 urgency episodes at Baseline. |
| Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0. |
| Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0. |
| Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Baseline up to Week 12 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Week 12 up to Week 26 (including 2 weeks of follow up after last dose) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events. |
| Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately. |
| Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Baseline, Week 24 | VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately. |
| Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. |
| Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Baseline, Week 24 | The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. |
| Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes. |
| Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Baseline, Week 24 | CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes. |
| Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes. |
| Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Baseline, Week 24 | CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes. |
| Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. |
| Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Baseline, Week 24 | The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. |
| Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Baseline up to Week 12 | Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of \<50 mmHg, b) change \>=20 mmHg increase, c) change \>=20 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate value \>120 bpm. |
| Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Baseline up to Week 24 | Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of \<50 mmHg, b) change \>=20 mmHg increase, c) change \>=20 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate value \>120 bpm. |
| Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | Week 1 up to Week 12 | Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 colony forming unit per milliliter \[CFU/mL\]) and the presence of symptoms, or pyuria (defined as \>50 white blood cells \[WBC\] per high-pass filter \[hpf\]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR). |
| Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | Week 12 up to Week 26 | Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) and the presence of symptoms, or pyuria (defined as \>50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR. |
| Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | Week 1 up to Week 12 | Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN), leukocytes \<0.6\*LLN\>1.5\*ULN, lymphocytes, neutrophils, \<0.8\*LLN \>1.2\*ULN, basophils, eosinophils, monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct, bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN, protein, albumin, phosphate \<0.8\*LLN \>1.2\*ULN, blood urea nitrogen, creatinine \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN, potassium, chloride, calcium bicarbonate\<0.9\*LLN\>1.1\*ULN, glucose\<0.6\*LLN\>1.5\*ULN, creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, \>=1, urine erythrocytes, urine leukocytes \>=20, epithelial cells \>=6, bacteria \>20. |
| Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | Week 12 up to Week 26 | Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN), leukocytes \<0.6\*LLN\>1.5\*ULN, lymphocytes, neutrophils, \<0.8\*LLN \>1.2\*ULN, basophils, eosinophils, monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct, bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN, protein, albumin, phosphate \<0.8\*LLN \>1.2\*ULN, blood urea nitrogen, creatinine \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN, potassium, chloride, calcium bicarbonate\<0.9\*LLN\>1.1\*ULN, glucose\<0.6\*LLN\>1.5\*ULN, creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, \>=1, urine erythrocytes, urine leukocytes \>=20, epithelial cells \>=6, bacteria \>20. |
| Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 4, 12 | Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. |
| Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | Baseline, Week 12 | Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. |
| Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | Baseline up to Week 12 | Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator. |
| Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | Baseline up to Week 24 | Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator. |
| Absorption Rate Constant (Ka) of Fesoterodine | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) | Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Apparent Oral Clearance (CL/F) of Fesoterodine | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) | Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Volume of Distribution (Vd) of Fesoterodine | Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach. |
| Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | Baseline, Week 24 | Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. |
Countries
Belgium, Canada, Estonia, Finland, France, Germany, Greece, India, Italy, Japan, Lithuania, Malaysia, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Study had 2 cohorts: cohort 1 had participants with body weight greater than (\>) 25 kilogram (kg) and cohort 2 had participants with body weight less than or equal to (\<=) 25 kg. There were 2 phases in each cohort: cohort 1- active comparator phase followed by safety extension phase; cohort 2- efficacy phase followed by safety extension phase.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Fesoterodine 4 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks. | 42 |
| Cohort 1: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks. | 42 |
| Cohort 1: Oxybutynin Participants with body weight \>25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase. | 40 |
| Cohort 2: Fesoterodine 2 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks. | 28 |
| Cohort 2: Fesoterodine 2 mg Then 4 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks. | 29 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Active Comparator/Efficacy Phase:12Weeks | Adverse Event | 2 | 0 | 0 | 0 | 0 | 2 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Failure to Meet Randomization Criteria | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Insufficient Clinical Response | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Active Comparator/Efficacy Phase:12Weeks | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Medication Error Without Associated AEs | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Other | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Protocol Violation | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Active Comparator/Efficacy Phase:12Weeks | Withdrawal By Parent/Guardian | 2 | 0 | 0 | 0 | 0 | 3 | 0 |
| Safety Extension Phase: 12 Weeks | Adverse Event | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Safety Extension Phase: 12 Weeks | Insufficient Clinical Response | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Safety Extension Phase: 12 Weeks | Medication Error Without Associated AEs | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Safety Extension Phase: 12 Weeks | Withdrawal By Parent/Guardian | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Fesoterodine 4 mg | Total | Cohort 2: Fesoterodine 2 mg Then 4 mg | Cohort 2: Fesoterodine 2 mg | Cohort 1: Oxybutynin | Cohort 1: Fesoterodine 4 mg Then 8 mg |
|---|---|---|---|---|---|---|
| Age, Customized >=10-12 Years | 15 Participants | 50 Participants | 5 Participants | 3 Participants | 13 Participants | 14 Participants |
| Age, Customized >=13-17 Years | 12 Participants | 39 Participants | 1 Participants | 1 Participants | 12 Participants | 13 Participants |
| Age, Customized >=6-9 Years | 15 Participants | 92 Participants | 23 Participants | 24 Participants | 15 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 173 Participants | 27 Participants | 28 Participants | 39 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 86 Participants | 16 Participants | 16 Participants | 22 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 88 Participants | 11 Participants | 12 Participants | 17 Participants | 24 Participants |
| Sex: Female, Male Female | 16 Participants | 86 Participants | 19 Participants | 12 Participants | 17 Participants | 22 Participants |
| Sex: Female, Male Male | 26 Participants | 95 Participants | 10 Participants | 16 Participants | 23 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 0 / 40 | 0 / 30 | 0 / 37 | 0 / 16 | 0 / 20 | 0 / 28 | 0 / 29 | 0 / 20 | 0 / 28 |
| other Total, other adverse events | 26 / 42 | 19 / 42 | 30 / 40 | 14 / 30 | 13 / 37 | 9 / 16 | 11 / 20 | 19 / 28 | 17 / 29 | 11 / 20 | 14 / 28 |
| serious Total, serious adverse events | 3 / 42 | 2 / 42 | 1 / 40 | 0 / 30 | 2 / 37 | 0 / 16 | 0 / 20 | 2 / 28 | 2 / 29 | 0 / 20 | 2 / 28 |
Outcome results
Primary
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O).
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | 58.12 milliliter |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | 83.36 milliliter |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | 87.17 milliliter |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | 23.49 milliliter |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | 40.17 milliliter |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.p-value: 0.0001ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.p-value: <0.0001ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.p-value: <0.0001ANCOVA
95% CI: [-71.42, 13.31]
95% CI: [-45.87, 38.23]
Secondary
Absorption Rate Constant (Ka) of Fesoterodine
Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Absorption Rate Constant (Ka) of Fesoterodine | 0.0897 per hour | Standard Error 5.99 |
Secondary
Apparent Oral Clearance (CL/F) of Fesoterodine
Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Apparent Oral Clearance (CL/F) of Fesoterodine | 71.6 liter per hour | Standard Error 6.7 |
Secondary
Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase
Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | 6.40 mL per cm H2O |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | 5.41 mL per cm H2O |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | 11.36 mL per cm H2O |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | 12.44 mL per cm H2O |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase | 16.44 mL per cm H2O |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.p-value: 0.0679ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.p-value: 0.1233ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.p-value: 0.0019ANCOVA
95% CI: [-14.81, 4.89]
95% CI: [-15.85, 3.95]
Secondary
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase
Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | 30.53 milliliter |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | 26.06 milliliter |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | 41.31 milliliter |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | 23.80 milliliter |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase | 31.26 milliliter |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.p-value: 0.0336ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.p-value: 0.0327ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.p-value: 0.0017ANCOVA
95% CI: [-48.75, 27.19]
95% CI: [-50.15, 19.64]
Secondary
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase
CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.92 T score | Standard Deviation 2.99 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 53.26 T score | Standard Deviation 3.52 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -1.03 T score | Standard Deviation 3.17 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -2.51 T score | Standard Deviation 4.63 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at week 12 | -1.97 T score | Standard Deviation 3.79 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -2.14 T score | Standard Deviation 6.46 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 56.45 T score | Standard Deviation 8.06 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -2.08 T score | Standard Deviation 5.26 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -1.73 T score | Standard Deviation 3.05 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 55.05 T score | Standard Deviation 8.2 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 49.48 T score | Standard Deviation 8.68 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | 0.35 T score | Standard Deviation 4.7 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 54.60 T score | Standard Deviation 5.17 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 56.29 T score | Standard Deviation 5.32 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.92 T score | Standard Deviation 4.69 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 55.00 T score | Standard Deviation 6.19 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.46 T score | Standard Deviation 5.99 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 61.14 T score | Standard Deviation 6.24 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Change at Week 12 | -1.35 T score | Standard Deviation 3.9 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 53.86 T score | Standard Deviation 5.67 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 56.07 T score | Standard Deviation 6.99 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Baseline | 57.52 T score | Standard Deviation 5.42 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.95 T score | Standard Deviation 3.71 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 57.00 T score | Standard Deviation 8.26 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -1.38 T score | Standard Deviation 5.25 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 54.32 T score | Standard Deviation 5.88 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 56.66 T score | Standard Deviation 7.47 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at week 12 | -1.40 T score | Standard Deviation 4.3 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 53.80 T score | Standard Deviation 5.53 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.88 T score | Standard Deviation 3.91 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Baseline | 58.54 T score | Standard Deviation 9.43 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Change at Week 12 | -2.55 T score | Standard Deviation 4.74 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 60.46 T score | Standard Deviation 8.73 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -1.28 T score | Standard Deviation 6.35 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 53.54 T score | Standard Deviation 5.93 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.48 T score | Standard Deviation 4.25 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 57.54 T score | Standard Deviation 8.34 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -1.25 T score | Standard Deviation 5.13 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 49.46 T score | Standard Deviation 10 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -2.33 T score | Standard Deviation 5.28 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 55.93 T score | Standard Deviation 12.84 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -2.35 T score | Standard Deviation 6.98 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 53.61 T score | Standard Deviation 11.98 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -3.23 T score | Standard Deviation 5.45 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Baseline | 57.95 T score | Standard Deviation 7.9 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Change at Week 12 | -0.67 T score | Standard Deviation 3.73 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -3.05 T score | Standard Deviation 7.12 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 60.58 T score | Standard Deviation 8.44 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.87 T score | Standard Deviation 7.16 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 56.73 T score | Standard Deviation 7.64 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 56.30 T score | Standard Deviation 5.68 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -1.59 T score | Standard Deviation 3.65 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 55.45 T score | Standard Deviation 10.28 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 58.25 T score | Standard Deviation 7.93 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -1.92 T score | Standard Deviation 5.08 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -1.92 T score | Standard Deviation 4.66 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 50.10 T score | Standard Deviation 9.73 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.95 T score | Standard Deviation 4.62 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 57.25 T score | Standard Deviation 11 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -1.28 T score | Standard Deviation 2.77 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at week 12 | -1.28 T score | Standard Deviation 3.69 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 53.43 T score | Standard Deviation 4.96 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 56.75 T score | Standard Deviation 7.32 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.72 T score | Standard Deviation 2.76 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 54.58 T score | Standard Deviation 5.75 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -2.36 T score | Standard Deviation 4.68 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 53.9 T score | Standard Deviation 10.34 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -1.71 T score | Standard Deviation 4.84 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.42 T score | Standard Deviation 1.67 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at week 12 | -1.29 T score | Standard Deviation 3.61 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 55.7 T score | Standard Deviation 5.96 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -0.79 T score | Standard Deviation 4.55 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 53.4 T score | Standard Deviation 10.7 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -1.75 T score | Standard Deviation 3.97 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 51.1 T score | Standard Deviation 9.83 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -1.29 T score | Standard Deviation 3.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 54.5 T score | Standard Deviation 4.96 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -2.63 T score | Standard Deviation 4.72 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Baseline | 57.9 T score | Standard Deviation 6.66 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 55.5 T score | Standard Deviation 6.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Change at Week 12 | -2.21 T score | Standard Deviation 4.38 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -1.96 T score | Standard Deviation 6.53 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 57.1 T score | Standard Deviation 6.47 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.38 T score | Standard Deviation 3.97 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 55.4 T score | Standard Deviation 5.06 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 54.9 T score | Standard Deviation 5.25 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 51.9 T score | Standard Deviation 2.81 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -2.17 T score | Standard Deviation 5.05 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 55.3 T score | Standard Deviation 5.74 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -3.52 T score | Standard Deviation 6.38 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.45 T score | Standard Deviation 4.56 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -1.38 T score | Standard Deviation 5.42 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -3.21 T score | Standard Deviation 5.27 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 52.3 T score | Standard Deviation 3.74 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at week 12 | -1.45 T score | Standard Deviation 3.41 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.03 T score | Standard Deviation 2.96 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 55.0 T score | Standard Deviation 7.11 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Change at Week 12 | -1.10 T score | Standard Deviation 3.41 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems : Baseline | 55.8 T score | Standard Deviation 5.9 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 52.8 T score | Standard Deviation 4.48 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -1.69 T score | Standard Deviation 5.9 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -0.59 T score | Standard Deviation 4.48 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 54.6 T score | Standard Deviation 10.14 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 52.7 T score | Standard Deviation 9.37 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.10 T score | Standard Deviation 2.19 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -3.38 T score | Standard Deviation 4.55 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 48.0 T score | Standard Deviation 7.84 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 56.3 T score | Standard Deviation 6.55 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 54.9 T score | Standard Deviation 5.6 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 58.4 T score | Standard Deviation 6.55 |
Secondary
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase
CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
Time frame: Baseline, Week 24
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -2.83 T score | Standard Deviation 4.12 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -5.21 T score | Standard Deviation 8.2 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -2.21 T score | Standard Deviation 3.99 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -3.45 T score | Standard Deviation 4.86 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.59 T score | Standard Deviation 3.85 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -4.38 T score | Standard Deviation 6.59 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.69 T score | Standard Deviation 4.33 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -7.03 T score | Standard Deviation 7.77 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -1.59 T score | Standard Deviation 3.62 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -7.69 T score | Standard Deviation 7.46 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -3.10 T score | Standard Deviation 5.45 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -4.44 T score | Standard Deviation 6.57 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -2.64 T score | Standard Deviation 6.58 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -2.56 T score | Standard Deviation 4.15 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -4.14 T score | Standard Deviation 7.62 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -2.31 T score | Standard Deviation 5.64 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.31 T score | Standard Deviation 4.57 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -2.89 T score | Standard Deviation 7.06 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -2.64 T score | Standard Deviation 5.72 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -1.50 T score | Standard Deviation 5.98 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -1.03 T score | Standard Deviation 4.52 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -1.47 T score | Standard Deviation 5.12 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -2.19 T score | Standard Deviation 3.9 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.25 T score | Standard Deviation 3.4 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.50 T score | Standard Deviation 3.76 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -3.38 T score | Standard Deviation 4.65 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -1.31 T score | Standard Deviation 4.01 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -3.19 T score | Standard Deviation 5.79 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -1.69 T score | Standard Deviation 9.2 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -3.25 T score | Standard Deviation 6.62 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -1.81 T score | Standard Deviation 5.42 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -3.25 T score | Standard Deviation 8.1 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -3.69 T score | Standard Deviation 6.74 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.70 T score | Standard Deviation 3.01 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -4.35 T score | Standard Deviation 5.24 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.90 T score | Standard Deviation 2.36 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -4.15 T score | Standard Deviation 7.44 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -4.90 T score | Standard Deviation 4.78 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -2.65 T score | Standard Deviation 3.28 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -5.35 T score | Standard Deviation 7.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -2.30 T score | Standard Deviation 3.5 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -1.50 T score | Standard Deviation 5.82 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -3.25 T score | Standard Deviation 5.66 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -2.40 T score | Standard Deviation 4.89 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -2.15 T score | Standard Deviation 3.17 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.60 T score | Standard Deviation 3.12 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -1.40 T score | Standard Deviation 3 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.50 T score | Standard Deviation 3.15 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -1.80 T score | Standard Deviation 5.43 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -2.60 T score | Standard Deviation 5.24 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -4.20 T score | Standard Deviation 5.15 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -5.20 T score | Standard Deviation 4.32 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -4.40 T score | Standard Deviation 6.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.70 T score | Standard Deviation 3.4 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -3.90 T score | Standard Deviation 4.35 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.86 T score | Standard Deviation 3.63 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -1.96 T score | Standard Deviation 6.77 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -5.25 T score | Standard Deviation 6.22 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Social problems : Change at Week 24 | -2.36 T score | Standard Deviation 4.17 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -4.32 T score | Standard Deviation 6.7 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.36 T score | Standard Deviation 2.63 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -3.89 T score | Standard Deviation 4.95 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.43 T score | Standard Deviation 3.75 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.71 T score | Standard Deviation 3.29 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -4.21 T score | Standard Deviation 6.86 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -1.75 T score | Standard Deviation 3.99 |
Secondary
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase
CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 3.83 units on a scale | Standard Deviation 3.33 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Change at Week 12 | -0.54 units on a scale | Standard Deviation 1.54 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.05 units on a scale | Standard Deviation 2.85 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 3.40 units on a scale | Standard Deviation 2.18 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at Week 12 | -1.05 units on a scale | Standard Deviation 2.25 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -0.89 units on a scale | Standard Deviation 3.62 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -4.92 units on a scale | Standard Deviation 8.73 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 5.83 units on a scale | Standard Deviation 5.23 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 2.05 units on a scale | Standard Deviation 2.23 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 1.64 units on a scale | Standard Deviation 1.48 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -0.97 units on a scale | Standard Deviation 1.46 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.62 units on a scale | Standard Deviation 2.35 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | 0.14 units on a scale | Standard Deviation 1.44 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 31.52 units on a scale | Standard Deviation 16.84 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.43 units on a scale | Standard Deviation 1.09 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 4.19 units on a scale | Standard Deviation 4.39 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 8.76 units on a scale | Standard Deviation 5.56 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 1.52 units on a scale | Standard Deviation 1.77 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.05 units on a scale | Standard Deviation 2.26 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Baseline | 3.60 units on a scale | Standard Deviation 2.3 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 4.79 units on a scale | Standard Deviation 3.18 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.46 units on a scale | Standard Deviation 1.69 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 4.66 units on a scale | Standard Deviation 4.46 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 1.46 units on a scale | Standard Deviation 2.34 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Change at Week 12 | -1.13 units on a scale | Standard Deviation 2.09 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 31.88 units on a scale | Standard Deviation 23.78 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.53 units on a scale | Standard Deviation 2.44 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 3.46 units on a scale | Standard Deviation 3.26 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 4.20 units on a scale | Standard Deviation 4.06 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -1.70 units on a scale | Standard Deviation 5.16 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 10.15 units on a scale | Standard Deviation 8.64 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -0.73 units on a scale | Standard Deviation 2.43 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.20 units on a scale | Standard Deviation 3.42 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 4.49 units on a scale | Standard Deviation 4.11 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -5.83 units on a scale | Standard Deviation 12.16 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 6.32 units on a scale | Standard Deviation 6.14 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at Week 12 | -0.73 units on a scale | Standard Deviation 2.16 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -0.35 units on a scale | Standard Deviation 1.59 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 1.66 units on a scale | Standard Deviation 1.98 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 2.49 units on a scale | Standard Deviation 2.78 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.30 units on a scale | Standard Deviation 1.36 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.90 units on a scale | Standard Deviation 2.56 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.10 units on a scale | Standard Deviation 1.37 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Baseline | 4.07 units on a scale | Standard Deviation 4.12 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 4.10 units on a scale | Standard Deviation 3.53 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 4.88 units on a scale | Standard Deviation 4.35 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.97 units on a scale | Standard Deviation 2.08 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -1.05 units on a scale | Standard Deviation 2.26 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 4.85 units on a scale | Standard Deviation 3.33 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at Week 12 | -0.77 units on a scale | Standard Deviation 2.03 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 1.70 units on a scale | Standard Deviation 1.87 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.38 units on a scale | Standard Deviation 0.99 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Baseline | 3.80 units on a scale | Standard Deviation 3.36 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Change at Week 12 | -0.26 units on a scale | Standard Deviation 1.57 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 3.40 units on a scale | Standard Deviation 3.23 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.51 units on a scale | Standard Deviation 2.64 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 2.58 units on a scale | Standard Deviation 2.92 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.51 units on a scale | Standard Deviation 1.3 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 2.75 units on a scale | Standard Deviation 2.66 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -0.64 units on a scale | Standard Deviation 1.77 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 6.53 units on a scale | Standard Deviation 5.87 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.31 units on a scale | Standard Deviation 2.3 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 10.25 units on a scale | Standard Deviation 7.02 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -2.21 units on a scale | Standard Deviation 4.35 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 34.18 units on a scale | Standard Deviation 22.16 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -5.85 units on a scale | Standard Deviation 9.77 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Baseline | 3.9 units on a scale | Standard Deviation 2.99 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.92 units on a scale | Standard Deviation 2.39 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.21 units on a scale | Standard Deviation 0.72 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | -0.63 units on a scale | Standard Deviation 1.56 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -5.33 units on a scale | Standard Deviation 8.29 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 1.9 units on a scale | Standard Deviation 1.63 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 29.5 units on a scale | Standard Deviation 17.41 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -0.50 units on a scale | Standard Deviation 1.1 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at Week 12 | -0.71 units on a scale | Standard Deviation 1.9 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 6.9 units on a scale | Standard Deviation 5.16 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 4.2 units on a scale | Standard Deviation 2.78 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -1.54 units on a scale | Standard Deviation 3.5 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -0.58 units on a scale | Standard Deviation 2.28 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 5.1 units on a scale | Standard Deviation 3.95 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 7.5 units on a scale | Standard Deviation 5.61 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 3.8 units on a scale | Standard Deviation 3.15 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 1.7 units on a scale | Standard Deviation 1.81 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -1.13 units on a scale | Standard Deviation 3.85 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 2.1 units on a scale | Standard Deviation 1.93 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.04 units on a scale | Standard Deviation 1.55 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Change at Week 12 | -0.83 units on a scale | Standard Deviation 1.86 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 1.0 units on a scale | Standard Deviation 1.04 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Baseline | 2.6 units on a scale | Standard Deviation 2.16 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Change at Week 12 | 0.52 units on a scale | Standard Deviation 3.45 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Change at Week 12 | -0.31 units on a scale | Standard Deviation 2.33 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Baseline | 3.2 units on a scale | Standard Deviation 2.64 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Change at Week 12 | -0.45 units on a scale | Standard Deviation 1.64 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Baseline | 4.0 units on a scale | Standard Deviation 3.35 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Rule-breaking behavior: Baseline | 1.0 units on a scale | Standard Deviation 1.3 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Social problems: Change at Week 12 | -0.62 units on a scale | Standard Deviation 1.52 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Baseline | 1.6 units on a scale | Standard Deviation 2.26 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Change at Week 12 | -2.21 units on a scale | Standard Deviation 3.91 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Change at Week 12 | -0.83 units on a scale | Standard Deviation 1.63 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Internalizing: Baseline | 8.2 units on a scale | Standard Deviation 6.13 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Change at Week 12 | -0.17 units on a scale | Standard Deviation 1.85 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Withdrawn: Change at Week 12 | -0.17 units on a scale | Standard Deviation 1.39 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Somatic complaints: Change at Week 12 | -0.55 units on a scale | Standard Deviation 2.03 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Attention problems: Baseline | 3.9 units on a scale | Standard Deviation 3.11 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Baseline | 27.0 units on a scale | Standard Deviation 16.59 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Total Problems: Change at Week 12 | -5.10 units on a scale | Standard Deviation 7.41 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Externalizing: Baseline | 4.5 units on a scale | Standard Deviation 4.32 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Thought problems: Baseline | 2.0 units on a scale | Standard Deviation 1.79 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Anxious/depressed: Change at Week 12 | -1.48 units on a scale | Standard Deviation 2.43 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase | Aggressive behavior: Baseline | 3.5 units on a scale | Standard Deviation 3.37 |
Secondary
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase
CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
Time frame: Baseline, Week 24
Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.41 units on a scale | Standard Deviation 2.31 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.34 units on a scale | Standard Deviation 2.92 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.24 units on a scale | Standard Deviation 1.43 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -1.31 units on a scale | Standard Deviation 1.95 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.93 units on a scale | Standard Deviation 2.22 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -10.90 units on a scale | Standard Deviation 11.98 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -3.52 units on a scale | Standard Deviation 4 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -1.34 units on a scale | Standard Deviation 2.22 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.28 units on a scale | Standard Deviation 1.53 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.62 units on a scale | Standard Deviation 1.29 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -1.97 units on a scale | Standard Deviation 3.5 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -8.58 units on a scale | Standard Deviation 12.86 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.28 units on a scale | Standard Deviation 2.42 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.36 units on a scale | Standard Deviation 2.77 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.17 units on a scale | Standard Deviation 3.1 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.50 units on a scale | Standard Deviation 1.65 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.19 units on a scale | Standard Deviation 1.97 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.89 units on a scale | Standard Deviation 2.38 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -0.36 units on a scale | Standard Deviation 1.4 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.44 units on a scale | Standard Deviation 2.01 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -2.61 units on a scale | Standard Deviation 4.95 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -1.67 units on a scale | Standard Deviation 4.27 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -2.63 units on a scale | Standard Deviation 4.65 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.88 units on a scale | Standard Deviation 3.32 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.69 units on a scale | Standard Deviation 1.35 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.50 units on a scale | Standard Deviation 1.21 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.94 units on a scale | Standard Deviation 2.35 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -1.19 units on a scale | Standard Deviation 3.23 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -0.81 units on a scale | Standard Deviation 2.43 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -1.06 units on a scale | Standard Deviation 2.14 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.06 units on a scale | Standard Deviation 1.88 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.13 units on a scale | Standard Deviation 2.33 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -9.00 units on a scale | Standard Deviation 13.45 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.20 units on a scale | Standard Deviation 1.36 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.55 units on a scale | Standard Deviation 0.94 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.60 units on a scale | Standard Deviation 2.48 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.25 units on a scale | Standard Deviation 1.77 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -1.35 units on a scale | Standard Deviation 1.66 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.45 units on a scale | Standard Deviation 1.73 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.75 units on a scale | Standard Deviation 3.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -10.10 units on a scale | Standard Deviation 10.47 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -2.30 units on a scale | Standard Deviation 4.03 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -0.90 units on a scale | Standard Deviation 1.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -3.40 units on a scale | Standard Deviation 4.68 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -9.45 units on a scale | Standard Deviation 7.93 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.80 units on a scale | Standard Deviation 1.01 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.65 units on a scale | Standard Deviation 1.81 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.15 units on a scale | Standard Deviation 0.88 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -2.30 units on a scale | Standard Deviation 3.64 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -2.20 units on a scale | Standard Deviation 2.84 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -0.65 units on a scale | Standard Deviation 1.04 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.40 units on a scale | Standard Deviation 2.41 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.70 units on a scale | Standard Deviation 2.36 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -1.15 units on a scale | Standard Deviation 1.76 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.45 units on a scale | Standard Deviation 1.5 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Total Problems: Change at Week 24 | -8.39 units on a scale | Standard Deviation 10.22 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Externalizing: Change at Week 24 | -1.79 units on a scale | Standard Deviation 3.28 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Aggressive behavior: Change at Week 24 | -1.57 units on a scale | Standard Deviation 2.7 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Anxious/depressed: Change at Week 24 | -1.75 units on a scale | Standard Deviation 2.34 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Attention problems: Change at Week 24 | -0.89 units on a scale | Standard Deviation 1.69 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Social problems: Change at Week 24 | -1.14 units on a scale | Standard Deviation 1.74 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Somatic complaints: Change at Week 24 | -0.68 units on a scale | Standard Deviation 2.04 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Thought problems: Change at Week 24 | -0.64 units on a scale | Standard Deviation 1.28 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Withdrawn: Change at Week 24 | -0.14 units on a scale | Standard Deviation 1.04 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Internalizing: Change at Week 24 | -2.57 units on a scale | Standard Deviation 3.63 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase | Rule-breaking behavior: Change at Week 24 | -0.18 units on a scale | Standard Deviation 0.94 |
Secondary
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase
Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | -2.86 cm H2O |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | -1.57 cm H2O |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | -2.39 cm H2O |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | -2.74 cm H2O |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase | -9.73 cm H2O |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.p-value: 0.2334ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.p-value: 0.5087ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.p-value: 0.3333ANCOVA
95% CI: [-7.28, 6.33]
95% CI: [-5.96, 7.6]
Secondary
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 catheterizations at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.30 catheterizations per 24 hours |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.32 catheterizations per 24 hours |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.34 catheterizations per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.10 catheterizations per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.22 catheterizations per 24 hours |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.p-value: 0.0787ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.p-value: 0.0727ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.p-value: 0.0666ANCOVA
95% CI: [-0.45, 0.54]
95% CI: [-0.49, 0.52]
Secondary
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 incontinence episodes at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.46 incontinence episodes per 24 hours |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.89 incontinence episodes per 24 hours |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -1.01 incontinence episodes per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.38 incontinence episodes per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.69 incontinence episodes per 24 hours |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.p-value: 0.0496ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.p-value: 0.0002ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.p-value: <0.0001ANCOVA
95% CI: [-0.09, 1.19]
95% CI: [-0.52, 0.77]
Secondary
Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.61 micturitions and catheterizations/24 hrs |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.60 micturitions and catheterizations/24 hrs |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.75 micturitions and catheterizations/24 hrs |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.24 micturitions and catheterizations/24 hrs |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.28 micturitions and catheterizations/24 hrs |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.p-value: 0.0111ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.p-value: 0.0171ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.p-value: 0.0028ANCOVA
95% CI: [-0.53, 0.82]
95% CI: [-0.54, 0.84]
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 micturitions at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -1.07 micturitions per 24 hours |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.68 micturitions per 24 hours |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.97 micturitions per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.37 micturitions per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.70 micturitions per 24 hours |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.p-value: 0.0116ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.p-value: 0.0765ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.p-value: 0.0061ANCOVA
95% CI: [-1.16, 0.97]
95% CI: [-0.74, 1.31]
Secondary
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase
The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with \>0 urgency episodes at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.62 urgency episodes per 24 hours |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.50 urgency episodes per 24 hours |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.14 urgency episodes per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.23 urgency episodes per 24 hours |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase | -0.62 urgency episodes per 24 hours |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.p-value: 0.0298ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.p-value: 0.1417ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.p-value: 0.6219ANCOVA
95% CI: [-1.28, 0.32]
95% CI: [-1.24, 0.52]
Secondary
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 29.47 milliliter per catheterization |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 47.18 milliliter per catheterization |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 45.90 milliliter per catheterization |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 11.50 milliliter per catheterization |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 1.74 milliliter per catheterization |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.p-value: 0.061ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.p-value: 0.0048ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.p-value: 0.01ANCOVA
95% CI: [-63.14, 30.29]
95% CI: [-46, 48.57]
Secondary
Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase
The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | 4.10 milliliter per micturition |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | 19.21 milliliter per micturition |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | 4.15 milliliter per micturition |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | -12.72 milliliter per micturition |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase | -8.41 milliliter per micturition |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.p-value: 0.7986ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.p-value: 0.2313ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.p-value: 0.7571ANCOVA
95% CI: [-42.11, 42]
95% CI: [-26.5, 56.63]
Secondary
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase
The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 18.45 mL per micturition or catheterization |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 55.55 mL per micturition or catheterization |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 36.69 mL per micturition or catheterization |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | 7.12 mL per micturition or catheterization |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase | -2.65 mL per micturition or catheterization |
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.p-value: 0.2246ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.p-value: 0.0003ANCOVA
Comparison: P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.p-value: 0.0161ANCOVA
95% CI: [-61, 24.53]
95% CI: [-22.93, 60.65]
Secondary
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.11 pegs | Standard Deviation 0.33 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.29 pegs | Standard Deviation 0.76 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.44 pegs | Standard Deviation 0.53 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.43 pegs | Standard Deviation 1.27 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.75 pegs | Standard Deviation 1.75 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 1.00 pegs | Standard Deviation 2 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.57 pegs | Standard Deviation 1.13 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 1.22 pegs | Standard Deviation 2.28 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.17 pegs | Standard Deviation 0.41 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.17 pegs | Standard Deviation 0.75 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.29 pegs | Standard Deviation 0.49 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.39 pegs | Standard Deviation 1.24 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 1.77 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0.68 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.35 pegs | Standard Deviation 0.86 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.60 pegs | Standard Deviation 3.45 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.76 pegs | Standard Deviation 2.26 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.05 pegs | Standard Deviation 0.52 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.10 pegs | Standard Deviation 0.45 |
Secondary
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | 0.33 pegs | Standard Deviation 0.58 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | 1.33 pegs | Standard Deviation 2.31 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | 0.43 pegs | Standard Deviation 0.79 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | 0.00 pegs | Standard Deviation 1.1 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | 0.50 pegs | Standard Deviation 0.71 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | -0.33 pegs | Standard Deviation 0.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | -0.27 pegs | Standard Deviation 1.39 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | -0.36 pegs | Standard Deviation 0.74 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at week 24 | -0.06 pegs | Standard Deviation 0.54 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at week 24 | 0.11 pegs | Standard Deviation 3.45 |
Secondary
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.45 pegs | Standard Deviation 1.2 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 1.05 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.91 pegs | Standard Deviation 2.36 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -0.33 pegs | Standard Deviation 1.6 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.24 pegs | Standard Deviation 0.5 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.06 pegs | Standard Deviation 1.03 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.18 pegs | Standard Deviation 0.58 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.28 pegs | Standard Deviation 0.46 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.21 pegs | Standard Deviation 1.78 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.09 pegs | Standard Deviation 0.77 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.36 pegs | Standard Deviation 0.78 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.24 pegs | Standard Deviation 0.66 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.10 pegs | Standard Deviation 0.32 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0.53 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.13 pegs | Standard Deviation 0.35 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.40 pegs | Standard Deviation 0.97 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 0.13 pegs | Standard Deviation 0.35 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.44 pegs | Standard Deviation 1.33 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 0.11 pegs | Standard Deviation 0.33 |
Secondary
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0.87 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -0.28 pegs | Standard Deviation 2.17 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.63 pegs | Standard Deviation 4.63 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.68 pegs | Standard Deviation 4.79 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.14 pegs | Standard Deviation 0.36 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0.39 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.25 pegs | Standard Deviation 1.24 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.27 pegs | Standard Deviation 1.67 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.60 pegs | Standard Deviation 0.89 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.44 pegs | Standard Deviation 1.33 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -0.13 pegs | Standard Deviation 0.35 |
Secondary
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.29 pegs | Standard Deviation 0.76 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -0.57 pegs | Standard Deviation 1.13 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 9.56 pegs | Standard Deviation 1.01 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 9.56 pegs | Standard Deviation 1.01 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 9.00 pegs | Standard Deviation 2.35 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 9.38 pegs | Standard Deviation 1.77 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 10.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 10.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0.38 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 9.89 pegs | Standard Deviation 0.47 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -0.07 pegs | Standard Deviation 0.62 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 9.82 pegs | Standard Deviation 0.73 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.00 pegs | Standard Deviation 0.32 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.11 pegs | Standard Deviation 0.46 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 9.62 pegs | Standard Deviation 1.2 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 10.0 pegs | Standard Deviation 0 |
Secondary
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -1.33 pegs | Standard Deviation 2.31 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -0.33 pegs | Standard Deviation 0.58 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.07 pegs | Standard Deviation 0.26 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.14 pegs | Standard Deviation 0.53 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.21 pegs | Standard Deviation 0.92 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
Secondary
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 24.45 pegs | Standard Deviation 2.09 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 25.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.07 pegs | Standard Deviation 0.25 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.53 pegs | Standard Deviation 2.19 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.42 pegs | Standard Deviation 1.77 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 24.56 pegs | Standard Deviation 1.89 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 24.75 pegs | Standard Deviation 0.92 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.26 pegs | Standard Deviation 0.93 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 25.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.03 pegs | Standard Deviation 0.3 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.12 pegs | Standard Deviation 0.7 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 24.88 pegs | Standard Deviation 0.42 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 25.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 0.63 pegs | Standard Deviation 1.77 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 24.50 pegs | Standard Deviation 1.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -0.13 pegs | Standard Deviation 0.35 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -0.63 pegs | Standard Deviation 1.77 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 23.22 pegs | Standard Deviation 3.83 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 0.11 pegs | Standard Deviation 2.76 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 24.25 pegs | Standard Deviation 1.75 |
Secondary
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.60 pegs | Standard Deviation 2.4 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.50 pegs | Standard Deviation 2.01 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.21 pegs | Standard Deviation 0.96 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.14 pegs | Standard Deviation 0.66 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.00 pegs | Standard Deviation 0 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 0.60 pegs | Standard Deviation 2.61 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | 0.11 pegs | Standard Deviation 2.76 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -0.50 pegs | Standard Deviation 1.85 |
Secondary
Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study.
Time frame: Baseline, Week 4, 12
Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure; Number Analyzed: participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 12 | 25.60 milliliter | Standard Deviation 53.42 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 4 | 5.40 milliliter | Standard Deviation 7.6 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline | 7.00 milliliter | Standard Deviation 8.2 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 12 | -4.00 milliliter | Standard Deviation 8.41 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline | 9.57 milliliter | Standard Deviation 12.54 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 4 | -7.33 milliliter | Standard Deviation 10.88 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 12 | 12.86 milliliter | Standard Deviation 43.48 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 4 | 19.11 milliliter | Standard Deviation 24.52 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline | 5.78 milliliter | Standard Deviation 7.98 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 12 | 2.50 milliliter | Standard Deviation 16.05 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline | 14.7 milliliter | Standard Deviation 14.31 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 4 | -2.00 milliliter | Standard Deviation 6.24 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Baseline | 10.7 milliliter | Standard Deviation 7.94 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 12 | 0.75 milliliter | Standard Deviation 17.46 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase | Change at Week 4 | 10.25 milliliter | Standard Deviation 34.4 |
Secondary
Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study.
Time frame: Baseline, Week 24
Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 11.50 milliliter | Standard Deviation 23.67 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 11.60 milliliter | Standard Deviation 29.43 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 18.00 milliliter | Standard Deviation 31.36 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 36.67 milliliter | Standard Deviation 59.23 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 21.67 milliliter | Standard Deviation 20.21 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase | 2.75 milliliter | Standard Deviation 14.5 |
Secondary
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 80.44 seconds | Standard Deviation 41.45 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 61.11 seconds | Standard Deviation 31.66 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -7.71 seconds | Standard Deviation 11.06 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -21.71 seconds | Standard Deviation 25.44 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 10.14 seconds | Standard Deviation 37.18 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 56.50 seconds | Standard Deviation 32.09 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | 15.33 seconds | Standard Deviation 49.28 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 114.00 seconds | Standard Deviation 89.43 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 46.43 seconds | Standard Deviation 16.28 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -2.00 seconds | Standard Deviation 12.25 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -5.33 seconds | Standard Deviation 6.15 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 48.00 seconds | Standard Deviation 15.14 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 69.56 seconds | Standard Deviation 58.52 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -19.36 seconds | Standard Deviation 81.03 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 91.29 seconds | Standard Deviation 110.76 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -11.20 seconds | Standard Deviation 41.11 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -3.25 seconds | Standard Deviation 22.53 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 52.20 seconds | Standard Deviation 31.06 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -10.26 seconds | Standard Deviation 27.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 76.29 seconds | Standard Deviation 76.71 |
Secondary
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -11.33 seconds | Standard Deviation 9.07 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -2.00 seconds | Standard Deviation 13.75 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -3.71 seconds | Standard Deviation 22.94 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -4.00 seconds | Standard Deviation 29.09 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | 1.50 seconds | Standard Deviation 10.61 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -2.00 seconds | Standard Deviation 8.49 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -6.33 seconds | Standard Deviation 3.06 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -11.00 seconds | Standard Deviation 5 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -9.14 seconds | Standard Deviation 14.33 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -7.07 seconds | Standard Deviation 6.8 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -18.47 seconds | Standard Deviation 38.13 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -15.00 seconds | Standard Deviation 28.54 |
Secondary
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Overall Number of Participants Analyzed: participants evaluable for this outcome measure, Number Analyzed: participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 110.61 seconds | Standard Deviation 59.63 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -9.10 seconds | Standard Deviation 19.94 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -5.40 seconds | Standard Deviation 10.43 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 88.85 seconds | Standard Deviation 24.22 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -8.88 seconds | Standard Deviation 20.76 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -4.10 seconds | Standard Deviation 10.79 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 92.15 seconds | Standard Deviation 40.51 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 109.00 seconds | Standard Deviation 49.75 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 82.64 seconds | Standard Deviation 24.32 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | 1.21 seconds | Standard Deviation 11.87 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -1.97 seconds | Standard Deviation 14 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 92.94 seconds | Standard Deviation 25.05 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 130.30 seconds | Standard Deviation 83.58 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 106.7 seconds | Standard Deviation 64.07 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -14.38 seconds | Standard Deviation 25.9 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -13.50 seconds | Standard Deviation 18.81 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Change at Week 12 | -12.50 seconds | Standard Deviation 20.3 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Baseline | 124.7 seconds | Standard Deviation 71.99 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Dominant hand: Change at Week 12 | -18.44 seconds | Standard Deviation 32.23 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase | Non-dominant hand: Baseline | 126.1 seconds | Standard Deviation 48.93 |
Secondary
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
Time frame: Baseline, Week 24
Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure and Number Analyzed: participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -8.20 seconds | Standard Deviation 11.67 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -9.24 seconds | Standard Deviation 15.79 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -12.27 seconds | Standard Deviation 18.28 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -8.46 seconds | Standard Deviation 10.42 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -5.71 seconds | Standard Deviation 9.55 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -3.79 seconds | Standard Deviation 11.89 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -7.00 seconds | Standard Deviation 13.25 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -11.87 seconds | Standard Deviation 14.15 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -38.20 seconds | Standard Deviation 31.67 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -38.00 seconds | Standard Deviation 29.35 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Dominant hand: Change at Week 24 | -17.00 seconds | Standard Deviation 33.16 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase | Non-dominant hand: Change at Week 24 | -15.50 seconds | Standard Deviation 29.11 |
Secondary
Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase
The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 11.88 centimeter | Standard Deviation 7.39 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 1.74 centimeter | Standard Deviation 7.45 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 12.31 centimeter | Standard Deviation 8.67 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.27 centimeter | Standard Deviation 4.29 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 15.94 centimeter | Standard Deviation 18.64 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 5.79 centimeter | Standard Deviation 36.75 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 7.77 centimeter | Standard Deviation 45.53 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 15.83 centimeter | Standard Deviation 17.85 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.81 centimeter | Standard Deviation 4.78 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 0.50 centimeter | Standard Deviation 4.64 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 9.69 centimeter | Standard Deviation 5.13 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 9.59 centimeter | Standard Deviation 5.05 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 9.67 centimeter | Standard Deviation 16.71 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | -1.04 centimeter | Standard Deviation 6.79 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | -1.45 centimeter | Standard Deviation 9.6 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 8.81 centimeter | Standard Deviation 14.89 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.90 centimeter | Standard Deviation 3.38 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 8.04 centimeter | Standard Deviation 7.17 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 1.02 centimeter | Standard Deviation 3.89 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 8.17 centimeter | Standard Deviation 6.89 |
Secondary
Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase
The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
Time frame: Baseline, Week 24
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.90 centimeter | Standard Deviation 5.85 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.73 centimeter | Standard Deviation 5.47 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 3.79 centimeter | Standard Deviation 29.81 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 4.33 centimeter | Standard Deviation 28.89 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 1.50 centimeter | Standard Deviation 4.8 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 1.66 centimeter | Standard Deviation 6.25 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.50 centimeter | Standard Deviation 4.3 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.58 centimeter | Standard Deviation 4.53 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | -1.35 centimeter | Standard Deviation 13.03 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.43 centimeter | Standard Deviation 11.53 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 1.12 centimeter | Standard Deviation 4.2 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.96 centimeter | Standard Deviation 4.38 |
Secondary
Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase
Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
Time frame: Baseline, Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 0.09 logMAR unit | Standard Deviation 0.16 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 0.01 logMAR unit | Standard Deviation 0.11 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 0.08 logMAR unit | Standard Deviation 0.16 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.00 logMAR unit | Standard Deviation 0.13 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 0.11 logMAR unit | Standard Deviation 0.19 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | -0.01 logMAR unit | Standard Deviation 0.1 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | -0.01 logMAR unit | Standard Deviation 0.1 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 0.10 logMAR unit | Standard Deviation 0.17 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.00 logMAR unit | Standard Deviation 0.13 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 0.02 logMAR unit | Standard Deviation 0.18 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 0.02 logMAR unit | Standard Deviation 0.13 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 0.03 logMAR unit | Standard Deviation 0.11 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 0.15 logMAR unit | Standard Deviation 0.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | 0.03 logMAR unit | Standard Deviation 0.12 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | -0.02 logMAR unit | Standard Deviation 0.08 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 0.16 logMAR unit | Standard Deviation 0.21 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Change at Week 12 | 0.00 logMAR unit | Standard Deviation 0.08 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Left Eye: Baseline | 0.14 logMAR unit | Standard Deviation 0.3 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Change at Week 12 | -0.00 logMAR unit | Standard Deviation 0.09 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase | Right Eye: Baseline | 0.10 logMAR unit | Standard Deviation 0.18 |
Secondary
Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase
VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
Time frame: Baseline, Week 24
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.04 logMAR unit | Standard Deviation 0.17 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.01 logMAR unit | Standard Deviation 0.19 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | -0.01 logMAR unit | Standard Deviation 0.11 |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | -0.02 logMAR unit | Standard Deviation 0.11 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | -0.01 logMAR unit | Standard Deviation 0.05 |
| Cohort 1, Active Comparator Phase: Oxybutynin | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.00 logMAR unit | Standard Deviation 0.08 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | -0.04 logMAR unit | Standard Deviation 0.09 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.02 logMAR unit | Standard Deviation 0.13 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.00 logMAR unit | Standard Deviation 0.07 |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | -0.02 logMAR unit | Standard Deviation 0.07 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Left Eye: Change at Week 24 | 0.03 logMAR unit | Standard Deviation 0.13 |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase | Right Eye: Change at Week 24 | 0.01 logMAR unit | Standard Deviation 0.11 |
Secondary
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase
Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of \<50 mmHg, b) change \>=20 mmHg increase, c) change \>=20 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate value \>120 bpm.
Time frame: Baseline up to Week 12
Population: Analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: <90 mmHg | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg increase | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: <50 mmHg | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg increase | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: >120 bpm | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: <90 mmHg | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: <50 mmHg | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg increase | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: >120 bpm | 4 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg increase | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: <50 mmHg | 2 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg increase | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: <90 mmHg | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg increase | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: <50 mmHg | 3 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg increase | 3 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg decrease | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: >120 bpm | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: <90 mmHg | 7 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: <50 mmHg | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: >120 bpm | 3 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: <90 mmHg | 4 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | SBP: Change >=30 mmHg increase | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase | DBP: Change >=20 mmHg increase | 4 Participants |
Secondary
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase
Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of \<50 mmHg, b) change \>=20 mmHg increase, c) change \>=20 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate value \>120 bpm.
Time frame: Baseline up to Week 24
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 3 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 4 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 2 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: >120 bpm | 1 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg increase | 2 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg decrease | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: <50 mmHg | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | DBP: Change >=20 mmHg decrease | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: Change >=30 mmHg increase | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | Pulse rate: <40 bpm | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase | SBP: <90 mmHg | 2 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase
Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN), leukocytes \<0.6\*LLN\>1.5\*ULN, lymphocytes, neutrophils, \<0.8\*LLN \>1.2\*ULN, basophils, eosinophils, monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct, bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN, protein, albumin, phosphate \<0.8\*LLN \>1.2\*ULN, blood urea nitrogen, creatinine \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN, potassium, chloride, calcium bicarbonate\<0.9\*LLN\>1.1\*ULN, glucose\<0.6\*LLN\>1.5\*ULN, creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, \>=1, urine erythrocytes, urine leukocytes \>=20, epithelial cells \>=6, bacteria \>20.
Time frame: Week 1 up to Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | 30 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | 29 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | 27 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | 19 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase | 19 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase
Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN), leukocytes \<0.6\*LLN\>1.5\*ULN, lymphocytes, neutrophils, \<0.8\*LLN \>1.2\*ULN, basophils, eosinophils, monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct, bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN, protein, albumin, phosphate \<0.8\*LLN \>1.2\*ULN, blood urea nitrogen, creatinine \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN, potassium, chloride, calcium bicarbonate\<0.9\*LLN\>1.1\*ULN, glucose\<0.6\*LLN\>1.5\*ULN, creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, \>=1, urine erythrocytes, urine leukocytes \>=20, epithelial cells \>=6, bacteria \>20.
Time frame: Week 12 up to Week 26
Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 19 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 22 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 7 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 12 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 15 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase | 21 Participants |
Secondary
Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase
Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
Time frame: Baseline up to Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here, Overall Number of Participants Analyzed: participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | 1 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase | 0 Participants |
Secondary
Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase
Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
Time frame: Baseline up to Week 24
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 3 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 2 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase | 2 Participants |
Secondary
Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase
Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 colony forming unit per milliliter \[CFU/mL\]) and the presence of symptoms, or pyuria (defined as \>50 white blood cells \[WBC\] per high-pass filter \[hpf\]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).
Time frame: Week 1 up to Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | 4 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | 4 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | 3 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase | 4 Participants |
Secondary
Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase
Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) and the presence of symptoms, or pyuria (defined as \>50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.
Time frame: Week 12 up to Week 26
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 1 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase | 5 Participants |
Secondary
Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase
In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.
Time frame: Baseline, Week 12
Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = No | 12 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = No | 9 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = Yes | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = Yes | 18 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = Yes | 18 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = Yes | 1 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = No | 4 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = No | 18 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = No | 6 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = Yes | 18 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = Yes | 0 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = No | 14 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = No | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = Yes | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = Yes | 19 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = No | 6 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = Yes | 16 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = Yes; Week 12 IDC = No | 11 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = Yes | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase | Baseline IDC = No; Week 12 IDC = No | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
Time frame: Baseline up to Week 12
Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent AEs | 26 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent SAEs | 3 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent SAEs | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent AEs | 20 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent SAEs | 1 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent AEs | 30 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent SAEs | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent AEs | 19 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent SAEs | 2 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase | Treatment Emergent AEs | 18 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
Time frame: Week 12 up to Week 26 (including 2 weeks of follow up after last dose)
Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 14 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 0 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 2 Participants |
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 13 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 9 Participants |
| Cohort 1, Active Comparator Phase: Oxybutynin | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 0 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 11 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 11 Participants |
| Cohort 2, Efficacy Phase: Fesoterodine 2 mg Then 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 0 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent SAEs | 2 Participants |
| Cohort 2, Safety Extension Phase: Fesoterodine 4 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase | Treatment emergent AEs | 16 Participants |
Secondary
Volume of Distribution (Vd) of Fesoterodine
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
Time frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)
Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1, Active Comparator Phase: Fesoterodine 4 mg | Volume of Distribution (Vd) of Fesoterodine | 68.1 liter | Standard Error 29.7 |