Detrusor Underactivity, Overactive Bladder
Conditions
Keywords
Lower Urinary Tract Symptoms
Brief summary
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
Detailed description
The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study. * Male; bladder contractility index (BCI) * Female; projected isovolumetric pressure (PIP) 1
Interventions
DRUGTAC-302
TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
DRUGPlacebo
Placebo administered orally twice per day after meals, for 12 weeks.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry * To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day. * To meet the detrusor underactivity criteria by urodynamic study Key
Exclusion criteria
* Neurogenic bladder by the central nervous system diseases. * StageIII or more cystocele of pelvic organ prolapse quantification system (women) * Prostate volume ≥30mL (Men) * Any symptoms of Urinary tract infection (UTI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Mean BCI for Male From Baseline to Week 12 | Baseline to Week 12 | BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 150, normal 100-150, and weak \< 100. No theoretical minimum and maximum value of the scale range exists. |
| Changes in the Mean PIP1 for Female From Baseline to Week 12 | Baseline to Week 12 | PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 75, normal 30-75, and weak \< 30. No theoretical minimum and maximum value of the scale range exists. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | Baseline to Week 12 | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. |
| Number of Micturitions Per 24 Hours at Baseline and Week 12 | Baseline to Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study. |
| Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | Baseline to Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study. |
| Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | Baseline to Week 12 | Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe. |
| Number of Participants With Adverse Events | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. |
| Changes in the Mean BVE From Baseline to Week 12 (Overall) | Baseline to Week 12 | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. |
| Number of Participants With Serious Adverse Events | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. |
| Number of Participants With Adverse Events Leading to Death | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | — |
| Number of Participants With Adverse Events Leading to Dose Discontinuation | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | — |
| Number of Participants With Adverse Events Leading to Dose Interruption | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. |
| Number of Participants With Adverse Drug Reactions | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) | — |
| Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | Baseline to Week 12 | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. |
Countries
Japan
Participant flow
Recruitment details
This study was conducted at 21 medical institutions in Japan and the study period was from September 9, 2017 to November 14, 2019. Of the 213 patients who gave informed consent and received screening tests, 18 patients were withdrawn at screening. The number of patients enrolled in the observation period was 195 patients, but after the end of the observation period, 76 patients were determined to be eligible for enrollment in the treatment period.
Participants by arm
| Arm | Count |
|---|---|
| TAC-302 TAC-302: TAC-302 200 mg administered orally twice per day after meals, for 12 weeks. | 42 |
| Placebo Placebo: Placebo administered orally twice per day after meals, for 12 weeks. | 18 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study treatment becomes impossible due to changing hospital or other reasons | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | TAC-302 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 74.0 years | 74.0 years | 73.5 years |
| Bladder contractility index (BCI) (Only Male) | 68.000 Score on a scale | 68.000 Score on a scale | 60.000 Score on a scale |
| Bladder voiding efficiency (BVE) | 65.15 % | 69.18 % | 73.46 % |
| Duration of lower urinary tract symptoms | 92.2 months STANDARD_DEVIATION 95.1 | 86.4 months STANDARD_DEVIATION 88.4 | 45.5 months |
| Projected isovolumetric pressure 1 (PIP1) (Only Female) | 18.769 Score on a scale STANDARD_DEVIATION 6.591 | 19.339 Score on a scale STANDARD_DEVIATION 6.773 | 20.561 Score on a scale STANDARD_DEVIATION 7.524 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants | 60 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 7 Participants |
| Sex: Female, Male Male | 27 Participants | 38 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 24 |
| other Total, other adverse events | 24 / 52 | 9 / 24 |
| serious Total, serious adverse events | 2 / 52 | 1 / 24 |
Outcome results
Primary
Changes in the Mean BCI for Male From Baseline to Week 12
BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 150, normal 100-150, and weak \< 100. No theoretical minimum and maximum value of the scale range exists.
Time frame: Baseline to Week 12
Population: PPS was used for the analysis. This analysis was conducted only in male patients in the PPS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Changes in the Mean BCI for Male From Baseline to Week 12 | BCI at baseline | 64.604 Score on a scale | Standard Deviation 16.569 |
| TAC-302 | Changes in the Mean BCI for Male From Baseline to Week 12 | BCI at Week 12 | 75.156 Score on a scale | Standard Deviation 21.076 |
| Placebo | Changes in the Mean BCI for Male From Baseline to Week 12 | BCI at baseline | 61.339 Score on a scale | Standard Deviation 16.629 |
| Placebo | Changes in the Mean BCI for Male From Baseline to Week 12 | BCI at Week 12 | 60.513 Score on a scale | Standard Deviation 16.708 |
Comparison: Baseline vs. Week 12 for the mean BCI in the TAC-302 groupp-value: <0.00195% CI: [5.514, 15.59]t-test, 2 sided
Comparison: Baseline vs. Week 12 for the mean BCI in the Placebo groupp-value: 0.81995% CI: [-8.676, 7.023]t-test, 2 sided
Comparison: TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12p-value: 0.01595% CI: [2.345, 20.411]t-test, 2 sided
Primary
Changes in the Mean PIP1 for Female From Baseline to Week 12
PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 75, normal 30-75, and weak \< 30. No theoretical minimum and maximum value of the scale range exists.
Time frame: Baseline to Week 12
Population: PPS was used for the analysis. This analysis was conducted only in female patients in the PPS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 at baseline | 18.769 Score on a scale | Standard Deviation 6.591 |
| TAC-302 | Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 at Week 12 | 29.373 Score on a scale | Standard Deviation 9.369 |
| Placebo | Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 at baseline | 20.561 Score on a scale | Standard Deviation 7.524 |
| Placebo | Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 at Week 12 | 25.487 Score on a scale | Standard Deviation 9.581 |
Comparison: Baseline vs. Week 12 for the mean PIP1 in the TAC-302 groupp-value: <0.00195% CI: [5.753, 15.455]t-test, 2 sided
Comparison: Baseline vs. Week 12 for the mean PIP1 in the Placebo groupp-value: 0.13895% CI: [-2.121, 11.973]t-test, 2 sided
Comparison: TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12p-value: 0.15795% CI: [-2.375, 13.731]t-test, 2 sided
Secondary
Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS. This analysis was conducted In the subgroup of patients with post void residual ≥ 100 mL at baseline in the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE at baseline | 32.10 percentage | Standard Deviation 20.16 |
| TAC-302 | Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE at Week 12 | 54.71 percentage | Standard Deviation 33.78 |
| Placebo | Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE at baseline | 44.03 percentage | Standard Deviation 19.42 |
| Placebo | Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE at Week 12 | 46.13 percentage | Standard Deviation 18.72 |
Comparison: Baseline vs. Week 12 for the mean BVE in the TAC-302 groupp-value: <0.00195% CI: [11.26, 35.88]t-test, 2 sided
Comparison: Baseline vs. Week 12 for the mean BVE in the Placebo groupp-value: 0.70895% CI: [-10.19, 14.4]t-test, 2 sided
Comparison: TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12p-value: 0.02595% CI: [2.96, 39.98]t-test, 2 sided
Secondary
Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS. This analysis was conducted in the subgroup of patients with post void residual ≥ 50 mL at baseline in the FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | BVE at baseline | 42.77 percentage | Standard Deviation 24.66 |
| TAC-302 | Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | BVE at Week 12 | 61.66 percentage | Standard Deviation 30.45 |
| Placebo | Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | BVE at baseline | 55.95 percentage | Standard Deviation 23.7 |
| Placebo | Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | BVE at Week 12 | 58.83 percentage | Standard Deviation 26.15 |
Comparison: Baseline vs. Week 12 for the mean BVE in the TAC-302 groupp-value: <0.00195% CI: [9.13, 27.69]t-test, 2 sided
Comparison: Baseline vs. Week 12 for the mean BVE in the Placebo groupp-value: 0.48995% CI: [-5.81, 11.58]t-test, 2 sided
Comparison: TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12p-value: 0.03195% CI: [1.48, 29.58]t-test, 2 sided
Secondary
Changes in the Mean BVE From Baseline to Week 12 (Overall)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE at baseline | 55.43 percentage | Standard Deviation 26.82 |
| TAC-302 | Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE at Week 12 | 66.79 percentage | Standard Deviation 27.04 |
| Placebo | Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE at baseline | 63.71 percentage | Standard Deviation 21.8 |
| Placebo | Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE at Week 12 | 65.69 percentage | Standard Deviation 28.98 |
Comparison: Baseline vs. Week 12 for the mean BVE in the TAC-302 groupp-value: 0.00695% CI: [3.22, 18.59]t-test, 2 sided
Comparison: Baseline vs. Week 12 for the mean BVE in the Placebo groupp-value: 0.5795% CI: [-6.27, 11.1]t-test, 2 sided
Comparison: TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12p-value: 0.17895% CI: [-3.96, 20.95]t-test, 2 sided
Secondary
Number of Micturitions Per 24 Hours at Baseline and Week 12
On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Number of Micturitions Per 24 Hours at Baseline and Week 12 | Number of micturitions per 24 hours at baseline | 11.753 Events | Standard Deviation 3.065 |
| TAC-302 | Number of Micturitions Per 24 Hours at Baseline and Week 12 | Number of micturitions per 24 hours at Week 12 | 10.830 Events | Standard Deviation 3.95 |
| Placebo | Number of Micturitions Per 24 Hours at Baseline and Week 12 | Number of micturitions per 24 hours at baseline | 11.764 Events | Standard Deviation 3.145 |
| Placebo | Number of Micturitions Per 24 Hours at Baseline and Week 12 | Number of micturitions per 24 hours at Week 12 | 10.174 Events | Standard Deviation 2.348 |
Secondary
Number of Participants With Adverse Drug Reactions
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAC-302 | Number of Participants With Adverse Drug Reactions | 0 Participants |
| Placebo | Number of Participants With Adverse Drug Reactions | 0 Participants |
Secondary
Number of Participants With Adverse Events
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAC-302 | Number of Participants With Adverse Events | Any adverse events | 24 Participants |
| TAC-302 | Number of Participants With Adverse Events | Deafness neurosensory | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Constipation | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Dental caries | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Diarrhea | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Diverticulum intestinal haemorrhagic | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Glossitis | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Haematochezia | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Nausea | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Vomiting | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Pyrexia | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Bacteriuria | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Bronchitis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Cystitis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Gastroenteritis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Herpes virus infection | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Influenza | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Nasopharyngitis | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Periodontitis | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Pharyngitis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Pyuria | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Urinary tract infection | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Vulvitis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Enteritis infectious | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Enterocolitis viral | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Compression fracture | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Fracture | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Subdural haematoma | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Contusion | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Post procedural haematuria | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Meniscus injury | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Tooth dislocation | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Blood creatinine phosphokinase increased | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Back pain | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Pain in extremity | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Headache | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events | Dysuria | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Renal colic | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Urethral pain | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Prostatitis | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Cough | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Dermatitis contact | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Miliaria | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events | Rash | 0 Participants |
| TAC-302 | Number of Participants With Adverse Events | Orthostatic hypotension | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Vulvitis | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Any adverse events | 9 Participants |
| Placebo | Number of Participants With Adverse Events | Prostatitis | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Deafness neurosensory | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Enteritis infectious | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Constipation | 2 Participants |
| Placebo | Number of Participants With Adverse Events | Pain in extremity | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Dental caries | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Enterocolitis viral | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Diarrhea | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Miliaria | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Diverticulum intestinal haemorrhagic | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Compression fracture | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Glossitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Headache | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Haematochezia | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Fracture | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Nausea | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Cough | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Vomiting | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Subdural haematoma | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Pyrexia | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Dysuria | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Bacteriuria | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Contusion | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Bronchitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Orthostatic hypotension | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Cystitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Post procedural haematuria | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Gastroenteritis | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Renal colic | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Herpes virus infection | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Meniscus injury | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Influenza | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Dermatitis contact | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Nasopharyngitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Tooth dislocation | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Periodontitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Urethral pain | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Pharyngitis | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Blood creatinine phosphokinase increased | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Pyuria | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Rash | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Urinary tract infection | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Back pain | 0 Participants |
Secondary
Number of Participants With Adverse Events Leading to Death
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAC-302 | Number of Participants With Adverse Events Leading to Death | 0 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Death | 0 Participants |
Secondary
Number of Participants With Adverse Events Leading to Dose Discontinuation
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAC-302 | Number of Participants With Adverse Events Leading to Dose Discontinuation | 0 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Dose Discontinuation | 0 Participants |
Secondary
Number of Participants With Adverse Events Leading to Dose Interruption
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAC-302 | Number of Participants With Adverse Events Leading to Dose Interruption | Any adverse events leading to dose interruption | 2 Participants |
| TAC-302 | Number of Participants With Adverse Events Leading to Dose Interruption | Enteritis infectious | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events Leading to Dose Interruption | Enterocolitis viral | 1 Participants |
| TAC-302 | Number of Participants With Adverse Events Leading to Dose Interruption | Diverticulum intestinal haemorrhagic | 0 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Dose Interruption | Diverticulum intestinal haemorrhagic | 1 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Dose Interruption | Any adverse events leading to dose interruption | 1 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Dose Interruption | Enterocolitis viral | 0 Participants |
| Placebo | Number of Participants With Adverse Events Leading to Dose Interruption | Enteritis infectious | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Population: All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAC-302 | Number of Participants With Serious Adverse Events | Any serious adverse events | 2 Participants |
| TAC-302 | Number of Participants With Serious Adverse Events | Prostatitis | 1 Participants |
| TAC-302 | Number of Participants With Serious Adverse Events | Subdural haematoma | 1 Participants |
| TAC-302 | Number of Participants With Serious Adverse Events | Diverticulum intestinal haemorrhagic | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events | Diverticulum intestinal haemorrhagic | 1 Participants |
| Placebo | Number of Participants With Serious Adverse Events | Any serious adverse events | 1 Participants |
| Placebo | Number of Participants With Serious Adverse Events | Subdural haematoma | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events | Prostatitis | 0 Participants |
Secondary
Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12
On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | Number of urinary urgency episodes per 24 hours at baseline | 5.452 Events | Standard Deviation 4.574 |
| TAC-302 | Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | Number of urinary urgency episodes per 24 hours at Week 12 | 4.469 Events | Standard Deviation 6.095 |
| Placebo | Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | Number of urinary urgency episodes per 24 hours at baseline | 5.701 Events | Standard Deviation 3.878 |
| Placebo | Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | Number of urinary urgency episodes per 24 hours at Week 12 | 2.493 Events | Standard Deviation 3.6 |
Secondary
Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12
Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe.
Time frame: Baseline to Week 12
Population: FAS was used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAC-302 | Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | OABSS total score at baseline | 8.7 points | Standard Deviation 2.9 |
| TAC-302 | Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | OABSS total score at Week 12 | 6.5 points | Standard Deviation 3.2 |
| Placebo | Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | OABSS total score at baseline | 8.9 points | Standard Deviation 2.4 |
| Placebo | Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | OABSS total score at Week 12 | 7.3 points | Standard Deviation 3 |