Phase 3
Completed N=148
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT01655069 ↗
Enrolled (actual)
148
Serious AEs
1.4%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) — 72; 10; 20; 8 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) |
72; 10; 20; 8; 1; 2 | — |
| SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours |
-0.92; -1.05; -1.11; -1.40; -1.28; -1.48 | — |
| SECONDARY Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days |
1.17; 1.69; 1.28; 2.21; 1.59; 1.94 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours |
-0.78; -1.29; -0.96; -1.38; -1.15; -1.15 | — |
| SECONDARY Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents |
-0.79; -1.36; -1.15; -1.31; -1.11; -2.18 | — |
| SECONDARY Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume |
1.3; 0.7 | — |
Eligibility Criteria
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 exclusion criteria of study 905-CL-076
Data sourced from ClinicalTrials.gov (NCT01655069). 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.