Phase 3
Completed N=789
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Source: ClinicalTrials.gov NCT00350636 ↗Enrolled (actual)
789
Serious AEs
2.2%
Results posted
May 2010
Primary outcomePrimary: Baseline Average Number of Daily Incontinence Episodes — 5.4; 5.4 Number of episodes
Summary
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Average Number of Daily Incontinence Episodes |
5.4; 5.4 | — |
| PRIMARY Change From Baseline in Average Daily Number of Incontinence Episodes |
-3.0; -2.5 | — |
| SECONDARY Baseline Average Daily Urinary Frequency |
12.4; 12.2 | — |
| SECONDARY Change From Baseline in Average Daily Urinary Frequency |
-2.7; -2.0 | — |
| SECONDARY Baseline Average Urine Void Volume |
163.4; 167.9 | — |
| SECONDARY Change From Baseline in Average Urine Void Volume |
21.0; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Females and males, 18 years of older with overactive bladder symptoms
Exclusion Criteria
- Treatable conditions that may cause urinary incontinence
- Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
Data sourced from ClinicalTrials.gov (NCT00350636). 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.