Phase 3
Completed N=189
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT01565707 ↗
Enrolled (actual)
189
Serious AEs
3.2%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition — 13.4; 25.5; 6.9; 2.3 mL — p=0.046
◆ Published Evidence
Established
42citations · ~5 / year
Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial.
Summary
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.
Linked Publications (3)
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Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial.
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Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition |
13.4; 25.5; 6.9; 2.3 | 0.046 sig |
| SECONDARY Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition |
11.3; 43.2; -8.4; -25.7 | 0.024 sig |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours |
-1.2; -1.1; -0.7; -0.6 | 0.763 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours |
-1.1; -1.2; -0.2; -0.8 | 0.402 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours |
-0.2; -0.1; -0.2; -0.2 | 0.630 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days |
1.7; 1.3; 1.5; 1.6 | 0.563 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days |
0.7; 0.4; -0.1; 0.4 | 0.770 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours |
-0.8; -1.1; -0.6; -0.4 | 0.303 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours |
-1.1; -1.2; -0.5; -0.3 | 0.640 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours |
0.0; -0.1; 0.4; 0.1 | 0.846 |
| SECONDARY Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents |
-0.7; -1.0 | — |
| SECONDARY Maximum Concentration (Cmax) of Solifenacin |
16.67; 26.24; 17.08; 33.48; 42.85 | — |
| SECONDARY Time to Attain Maximum Concentration (Tmax) of Solifenacin |
2.933; 3.175; 2.8; 2.874; 2.85 | — |
| SECONDARY Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin |
9.534; 16.1; 8.828; 19.05; 27.94 | — |
| SECONDARY Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin |
298.7; 452.8; 269.2; 560; 745.7 | — |
| SECONDARY Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin |
27.3; 30.98; 24.84; 26.85; 41.27 | — |
| SECONDARY Apparent Total Body Clearance (CL/F) of Solifenacin |
6.968; 7.608; 14.56; 8.773; 11.3 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Solifenacin |
272.4; 329.5; 521.9; 315.7; 561.7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
45; 44; 12; 9; 9; 14 | — |
| SECONDARY Change From Baseline in Post Void Residual (PVR) Volume |
0.07; -0.99; -3.58; 0.95 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Written Informed Consent has been obtained
- OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
- Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary
Main Exclusion Criteria:
- Daily voiding frequency less than 5
- Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
- Uroflow indicative of pathology other than OAB
- Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
- Post Void Residual (PVR) > 20 ml
- Monosymptomatic enuresis
- Polyuria defined as > 75 ml/kg/b.w./24 hours
- Dysfunctional voiding
- Congenital anomalies affecting lower urinary tract function
- Current constipation
- Current Urinary Tract Infection (UTI)
- Catheterization within 2 weeks prior to screening
Data sourced from ClinicalTrials.gov (NCT01565707) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.