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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002066-20 | EudraCT Number |
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Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.
This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Children | Placebo Comparator | Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks. |
|
| Solifenacin Succinate Suspension Children | Experimental | Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
|
| Placebo Adolescents | Placebo Comparator | Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. |
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| Solifenacin Succinate Suspension Adolescents | Placebo Comparator | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin Succinate Suspension | Drug | Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition | The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition | The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 1006 | Shreveport | Louisiana | 71106 | United States | ||
| Site: 1015 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33231929 | Derived | Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684. | |
| 32239291 | Derived | Snijder R, Bosman B, Stroosma O, Agema M. Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial. Eur J Pediatr. 2020 Oct;179(10):1523-1528. doi: 10.1007/s00431-020-03635-2. Epub 2020 Apr 1. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Subjects received 4 weeks of urotherapy (standard first line therapy for pediatric OAB patients). Two weeks after start of urotherapy a single-blind 2-week placebo run-in period began. After run-in period eligible subjects were randomized to 12 weeks of double-blind treatment (solifenacin succinate suspension or placebo) and continued urotherapy.
The study population consisted of male and female children (5 to 11 years old) and adolescents (12 to 17 years old) with overactive bladder (OAB).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Children | Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks. |
| FG001 | Solifenacin Succinate Suspension Children | Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary. |
|
| Urotherapy | Behavioral | Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. |
|
|
| Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days | The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days | The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day. | Baseline and week 12 |
| Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning. | Baseline and Week 12 |
| Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. | Baseline and Week 12 |
| Maximum Concentration (Cmax) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS). | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Time to Attain Maximum Concentration (Tmax) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Apparent Total Body Clearance (CL/F) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Apparent Volume of Distribution (Vz/F) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
| Number of Participants With Adverse Events (AEs) | A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication. | From the first dose of study drug until 7 days after last dose of study medication (13 weeks). |
| Change From Baseline in Post Void Residual (PVR) Volume | Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan. | Baseline and Week 12 |
| Albany |
| New York |
| 12208 |
| United States |
| Site: 3202 | Antwerp | 2020 | Belgium |
| Site: 3209 | Antwerp | 2650 | Belgium |
| Site: 3208 | Charleroi | 6000 | Belgium |
| Site: 3201 | Ghent | 9000 | Belgium |
| Site: 3203 | Ghent | 9000 | Belgium |
| Site: 3204 | Kortrijk | 8500 | Belgium |
| Site: 3205 | Leuven | 3000 | Belgium |
| Site: 5507 | Campinas | 13087-567 | Brazil |
| Site: 5506 | Curitiba | 80240-060 | Brazil |
| Site: 1005 | Hamilton | L8N 3Z5 | Canada |
| Site: 1001 | Québec | G1V 4G2 | Canada |
| Site: 4503 | Aalborg | DK-9000 | Denmark |
| Site: 4501 | Aarhus N | 8200 | Denmark |
| Site: 4502 | Kolding | 6000 | Denmark |
| Site: 4504 | Køge | 4600 | Denmark |
| Site: 5202 | Mexico City | 4530 | Mexico |
| Site: 5205 | Mexico City | C.P.06700 | Mexico |
| Site: 4701 | Bergen | 5021 | Norway |
| Site: 4702 | Trondheim | 7030 | Norway |
| Site: 6301 | Quezon City | 1108 | Philippines |
| Site: 4805 | Gdansk | 80-803 | Poland |
| Site: 4803 | Gdansk | 80-952 | Poland |
| Site: 4804 | Lubin | 20-093 | Poland |
| Site: 4801 | Warsaw | 04-736 | Poland |
| Site: 3810 | Belgrade | 11 000 | Serbia and Montenegro |
| Site: 3812 | Novi Sad | 21000 | Serbia and Montenegro |
| Site: 2703 | Cape Town | 7700 | South Africa |
| Site:8203 | Daegu | 705717 | South Korea |
| Site: 8206 | Incheon | 400-711 | South Korea |
| Site: 8207 | Seoul | 110744 | South Korea |
| Site: 8201 | Seoul | 120752 | South Korea |
| Site:8202 | Seoul | 156707 | South Korea |
| Site: 4606 | Gothenburg | 41685 | Sweden |
| Site: 4601 | Jönköping | 55185 | Sweden |
| Site: 4603 | Skövde | 54185 | Sweden |
| Site: 4602 | Stockholm | 11883 | Sweden |
| Site: 4605 | Umeå | 90185 | Sweden |
| Site: 9001 | Ankara | 6100 | Turkey (Türkiye) |
| Site: 9002 | Izmir | 35100 | Turkey (Türkiye) |
| Site: 3853 | Dnipropetrovsk | 49100 | Ukraine |
| Site: 3854 | Kharkiv | Ukraine |
| Site: 3850 | Kiev | 1103 | Ukraine |
| Site: 4403 | Leeds | LS1 3EX | United Kingdom |
| Site: 4401 | Sheffield | S10 2TH | United Kingdom |
| 27687820 | Derived | Newgreen D, Bosman B, Hollestein-Havelaar A, Dahler E, Besuyen R, Sawyer W, Bolduc S, Rittig S. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Eur Urol. 2017 Mar;71(3):483-490. doi: 10.1016/j.eururo.2016.08.061. Epub 2016 Sep 28. |
| FG002 | Placebo Adolescents | Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. |
| FG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline values provided are based on the Safety Analysis Set (SAF) population and the Full Analysis Set (FAS). Population analysis is defined within each baseline measure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Children | Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks. |
| BG001 | Solifenacin Succinate Suspension Children | Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
| BG002 | Placebo Adolescents | Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. |
| BG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age values provided are for the Safety Analysis Set (SAF) population. The SAF consisted of all participants who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug. The number of participants was 73; 73; 19; 22 per treatment arm. | Mean | Standard Deviation | years |
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| Sex: Female, Male | SAF population. The number of participants was 73; 73: 19; 22 per treatment arm. | Count of Participants | Participants |
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| Race | SAF population. The number of participants was 73; 73; 19; 22 per treatment arm. | Number | Participants |
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| Ethnicity | SAF population. The number of participants was 73; 73; 19; 22 per treatment arm. | Number | Participants |
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| Mean Volume Voided (MVV) per Micturition | Values for this baseline characteristic are based on the Full Analysis Set (FAS). The FAS consisted of all randomized patients that took at least 1 dose of double-blind study medication after randomization and provided a valid baseline and post baseline value for the primary efficacy endpoint. A micturition is any voluntary urination, excluding episodes of incontinence only. Micturitions voided volumes were recorded in a patient diary for any 2 days in the 7 day period prior to the baseline visit (referred to as "measuring days"). The number of participants was 70; 73; 19; 21 per arm. | Mean | Standard Deviation | mL |
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| Daytime Maximum Volume Voided (DMaxVV) Per Micturition | FAS population. The mean DMaxVV was determined using the patient diary data recorded during two measuring days (i.e., days when the patient recorded the volume of each micturition) in the 7 days prior to the baseline visit. The DMaxVV is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary (first morning void excluded). Daytime defined as time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 73; 19; 21 per treatment arm. | Mean | Standard Deviation | mL |
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| Mean Number of Incontinence Episodes per 24 Hours | FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. An incontinence episode is defined as an episode with any involuntary loss of urine. The number of participants was 70; 73; 19; 21 per treatment arm. | Mean | Standard Deviation | incontinence episodes |
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| Mean Number of Daytime Incontinence Episodes per 24 Hours | FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. Daytime is defined as the time between waking up in the morning and going to bed later the same day. An incontinence episode is defined as an episode with any involuntary loss of urine. The number of participants was 70; 71; 19; 21 per treatment arm. | Mean | Standard Deviation | daytime incontinence episodes |
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| Mean Number of Nighttime Incontinence Episodes per 24 Hours | FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. The number of participants was 70; 71; 19; 21 per treatment arm. | Mean | Standard Deviation | nighttime incontinence episodes |
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| Number of Dry (Incontinence-free) Days per 7 Days | FAS population. The mean of the number of dry days was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was 70; 73; 19; 21 per treatment arm. | Mean | Standard Deviation | Dry Days |
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| Number of Dry (Incontinence-free) Nights per 7 Days | FAS population. The mean of the number of dry nights was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was 70; 73; 19; 21 per treatment arm. | Mean | Standard Deviation | Dry Nights |
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| Mean Number of Micturitions per 24 Hours | FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 73; 19; 21 per treatment arm. | Mean | Standard Deviation | micturitions |
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| Mean Number of Daytime Micturitions per 24 Hours | FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 71; 19; 21 per treatment arm. | Mean | Standard Deviation | daytime micturitions |
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| Mean Number of Nighttime Micturitions per 24 Hours | FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 71; 19; 21 per treatment arm. | Mean | Standard Deviation | nighttime micturitions |
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| Mean Number of Grade 3 or 4 Urgency Episodes per 24 Hours in Adolescents | FAS population. Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was N/A; N/A; 19; 20 per treatment arm. | Mean | Standard Deviation | urgency episodes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition | The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence. | Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition | The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | mL | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | incontinence episodes | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day. | Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | Standard Error | daytime incontinence episodes | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours | The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | nighttime incontinence episodes | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days | The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | Dry Days | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days | The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | Dry Nights | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | micturitions | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | daytime micturitions | Baseline and week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours | The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning. | The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method. | Posted | Least Squares Mean | Standard Error | nighttime micturitions | Baseline and Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents | Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. | The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | Standard Error | urgency episodes | Baseline and Week 12 |
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| Secondary | Maximum Concentration (Cmax) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS). | The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known. | Posted | Mean | Standard Deviation | ng/mL | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Time to Attain Maximum Concentration (Tmax) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | hours | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | ng/mL | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | ng*h/mL | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | hours | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Apparent Total Body Clearance (CL/F) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | L/h | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Solifenacin | Pharmacokinetic sampling was performed at steady state at the end of treatment. | The study analysis population for this endpoint consisted of the PKAS. | Posted | Mean | Standard Deviation | L | Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). |
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| Secondary | Number of Participants With Adverse Events (AEs) | A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication. | The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug. | Posted | Number | participants | From the first dose of study drug until 7 days after last dose of study medication (13 weeks). |
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| Secondary | Change From Baseline in Post Void Residual (PVR) Volume | Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan. | The study analysis population for this endpoint consisted of the SAF. | Posted | Least Squares Mean | Standard Deviation | mL | Baseline and Week 12 |
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From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Children | Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks. | 2 | 73 | 26 | 73 | ||
| EG001 | Solifenacin Succinate Suspension Children | Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. | 2 | 73 | 28 | 73 | ||
| EG002 | Placebo Adolescents | Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks. | 1 | 19 | 12 | 19 | ||
| EG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. | 1 | 22 | 5 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v13.0. | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA v13.0. | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Frontal lobe epilepsy | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v13.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v13.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA v13.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v13.0 | Systematic Assessment |
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| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
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Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 90 days prior to publication for review and comment. Sponsor may delay the publication temporarily to seek patent protection or permanently withhold the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Medical Science - Urology | Astellas Pharma Europe B.V. | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Adolescents |
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| Male |
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| Black/African American |
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| Asian |
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| American Indian/Alaskan Native |
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| Other |
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| Not Hispanic or Latino |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adolescents |
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| Adjusted Mean Difference | -4.7 | Standard Error of the Mean | 15.7 | 2-Sided | 95 | -36.7 | 27.4 | From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate. | Superiority or Other (legacy) |
| OG002 | Placebo Adolescents | Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. |
| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
|
|
|
| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
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| OG003 | Children PED 10 | Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
|
Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
|
Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
|
Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
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| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
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| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
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| OG004 | Adolescents PED 10 | Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension |
|
|
| OG003 | Solifenacin Succinate Suspension Adolescents | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
|
|
Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
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