Urinary Bladder, Overactive
Conditions
Keywords
Overactive bladder (OAB), Solifenacin succinate suspension, Phase 3, Pediatric
Brief summary
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
Detailed description
There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.
Interventions
Oral suspension
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076
Exclusion criteria
* Subject has failed the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076). | The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment | The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. |
| Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment | The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment | The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. |
| Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment | Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group. |
| Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume | Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.) | PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks. |
Countries
Belgium, Brazil, Canada, Denmark, Mexico, Norway, Philippines, Poland, Serbia and Montenegro, South Africa, South Korea, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants recruited for this study were children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder (OAB), who completed the 2-week placebo run-in period and 12-week treatment period of Study 905-CL-076 (NCT01565707).
Pre-assignment details
Children and adolescents with OAB, who completed study 905-CL-076, consented to enter this study and fulfilled all the eligibility criteria were enrolled at Week 12/13 (2-3 days after last dose was received during the 905-CL-076 study). The age of participant at informed consent signing in 905-CL-076 determined the age group in this study.
Participants by arm
| Arm | Count |
|---|---|
| Children Treated With Placebo in 905-CL-076 Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children. | 61 |
| Children Treated With Solifenacin in 905-CL-076 Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children. | 57 |
| Adolescents Treated With Placebo in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents. | 14 |
| Adolescents Treated With Solifenacin in 905-CL-076 Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents. | 15 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 7 | 2 | 3 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 |
| Overall Study | No Treatment Needed | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Adolescents Treated With Placebo in 905-CL-076 | Adolescents Treated With Solifenacin in 905-CL-076 | Total | Children Treated With Placebo in 905-CL-076 | Children Treated With Solifenacin in 905-CL-076 |
|---|---|---|---|---|---|
| Age, Continuous Adolescents | 13.9 Years STANDARD_DEVIATION 1.6 | 14.5 Years STANDARD_DEVIATION 1.8 | 14.2 Years STANDARD_DEVIATION 1.7 | — | — |
| Age, Continuous Children | — | — | 7.3 Years STANDARD_DEVIATION 1.6 | 7.2 Years STANDARD_DEVIATION 1.6 | 7.5 Years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 17 Participants | 7 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 14 Participants | 130 Participants | 54 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 7 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 11 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 7 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 12 Participants | 119 Participants | 49 Participants | 47 Participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 85 Participants | 27 Participants | 34 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 62 Participants | 34 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 29 |
| other Total, other adverse events | 70 / 118 | 16 / 29 |
| serious Total, serious adverse events | 1 / 118 | 1 / 29 |
Outcome results
Primary
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.
Time frame: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).
Population: Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Mild | 72 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Moderate | 20 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Severe | 1 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 93 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug-related TEAEs | 41 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Serious TEAEs | 1 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug-related serious TEAEs | 0 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation | 12 Participants |
| Children (Aged 5 to Less Than 12 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug related TEAEs leading to permanent discont. | 12 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug-related serious TEAEs | 0 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Mild | 10 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Moderate | 8 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug related TEAEs leading to permanent discont. | 4 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAE - Severe | 2 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Serious TEAEs | 1 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 20 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation | 5 Participants |
| Adolescents (Aged 12 to Less Than 18 Years) | Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) | Drug-related TEAEs | 11 Participants |
Secondary
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.
Time frame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Population: Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 3 weeks solifenacin treatment | -0.79 urgency episodes | Standard Error 0.26 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 6 weeks solifenacin treatment | -1.36 urgency episodes | Standard Error 0.53 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 9 weeks solifenacin treatment | -1.15 urgency episodes | Standard Error 0.54 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 12 weeks solifenacin treatment | -1.31 urgency episodes | Standard Error 0.38 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 24weeks solifenacin treatment | -1.11 urgency episodes | Standard Error 0.47 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 40 weeks solifenacin treatment | -2.18 urgency episodes | Standard Error 0.81 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | 52 weeks solifenacin treatment | -1.87 urgency episodes | Standard Error 0.44 |
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.65, 0.17]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.23, -0.36]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.06, -0.22]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.18, -0.38]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-1.95, -0.12]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.93, -1]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-3.48, -0.93]Repeated Measures ANCOVA
Secondary
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.
Time frame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Population: Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 9 weeks solifenacin treatment | -1.28 incontinence episodes | Standard Error 0.19 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 24 weeks solifenacin treatment | -1.61 incontinence episodes | Standard Error 0.19 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 6 weeks solifenacin treatment | -1.11 incontinence episodes | Standard Error 0.17 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 40 weeks solifenacin treatment | -1.66 incontinence episodes | Standard Error 0.23 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 12 weeks solifenacin treatment | -1.39 incontinence episodes | Standard Error 0.2 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 52 weeks solifenacin treatment | -1.56 incontinence episodes | Standard Error 0.22 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 3 weeks solifenacin treatment | -0.92 incontinence episodes | Standard Error 0.18 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 52 weeks solifenacin treatment | -1.34 incontinence episodes | Standard Error 0.38 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 3 weeks solifenacin treatment | -1.05 incontinence episodes | Standard Error 0.34 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 6 weeks solifenacin treatment | -1.40 incontinence episodes | Standard Error 0.33 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 9 weeks solifenacin treatment | -1.48 incontinence episodes | Standard Error 0.38 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 12 weeks solifenacin treatment | -1.66 incontinence episodes | Standard Error 0.39 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 24 weeks solifenacin treatment | -1.73 incontinence episodes | Standard Error 0.39 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | 40 weeks solifenacin treatment | -1.49 incontinence episodes | Standard Error 0.36 |
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.19, -0.71]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.34, -0.88]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.53, -1]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.63, -1.16]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.76, -1.32]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-1.81, -1.31]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.19, -1.67]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.62, -0.23]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-2.09, -0.68]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.09, -0.7]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.27, -0.88]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.5, -1.1]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.29, -0.85]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.83, -1.17]Repeated Measures ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.
Time frame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Population: Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 40 weeks solifenacin treatment | -1.43 micturitions | Standard Error 0.24 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 3 weeks solifenacin treatment | -0.78 micturitions | Standard Error 0.18 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 6 weeks solifenacin treatment | -0.96 micturitions | Standard Error 0.2 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 9 weeks solifenacin treatment | -1.15 micturitions | Standard Error 0.2 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 12 weeks solifenacin treatment | -1.09 micturitions | Standard Error 0.21 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 24 weeks solifenacin treatment | -1.42 micturitions | Standard Error 0.21 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 52 weeks solifenacin treatment | -1.80 micturitions | Standard Error 0.43 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 40 weeks solifenacin treatment | -1.39 micturitions | Standard Error 0.75 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 12 weeks solifenacin treatment | -1.24 micturitions | Standard Error 0.49 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 3 weeks solifenacin treatment | -1.29 micturitions | Standard Error 0.39 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 52 weeks solifenacin treatment | -0.81 micturitions | Standard Error 0.34 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 6 weeks solifenacin treatment | -1.38 micturitions | Standard Error 0.63 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 24 weeks solifenacin treatment | -1.01 micturitions | Standard Error 0.49 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | 9 weeks solifenacin treatment | -1.15 micturitions | Standard Error 0.61 |
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.27, -0.69]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-1.44, -0.86]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-1.6, -1.02]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant95% CI: [-1.51, -0.93]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.8, -1.21]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.83, -1.22]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.22, -1.43]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.73, -0.13]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.48, -0.4]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.46, -0.17]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.53, -0.28]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.8, -0.38]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-1.92, -0.44]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [-2.59, -1]Repeated Measures ANCOVA
Secondary
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.
Time frame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Population: Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 9 weeks solifenacin treatment | 1.59 days | Standard Error 0.21 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 24 weeks solifenacin treatment | 2.09 days | Standard Error 0.22 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 6 weeks solifenacin treatment | 1.28 days | Standard Error 0.19 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 40 weeks solifenacin treatment | 2.15 days | Standard Error 0.25 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 12 weeks solifenacin treatment | 1.60 days | Standard Error 0.21 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 52 weeks solifenacin treatment | 2.57 days | Standard Error 0.4 |
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 3 weeks solifenacin treatment | 1.17 days | Standard Error 0.16 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 52 weeks solifenacin treatment | 3.27 days | Standard Error 0.73 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 3 weeks solifenacin treatment | 1.69 days | Standard Error 0.53 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 6 weeks solifenacin treatment | 2.21 days | Standard Error 0.56 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 9 weeks solifenacin treatment | 1.94 days | Standard Error 0.5 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 12 weeks solifenacin treatment | 2.89 days | Standard Error 0.51 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 24 weeks solifenacin treatment | 3.19 days | Standard Error 0.51 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days | 40 weeks solifenacin treatment | 2.71 days | Standard Error 0.59 |
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [0.97, 1.73]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.02, 1.83]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.27, 2.16]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.36, 2.24]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.74, 2.67]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.79, 2.77]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [2.19, 3.49]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [0.17, 2.89]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [0.52, 3.27]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [0.39, 3.1]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.34, 4.05]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.7, 4.43]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [1.05, 3.85]Repeated Measures ANCOVA
Comparison: Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant.95% CI: [2.34, 5.53]Repeated Measures ANCOVA
Secondary
Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.
Time frame: Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)
Population: Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children (Aged 5 to Less Than 12 Years) | Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume | 1.3 mL | Standard Deviation 11.9 |
| Adolescents (Aged 12 to Less Than 18 Years) | Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume | 0.7 mL | Standard Deviation 8.8 |