Trials / Completed
CompletedNCT03475706
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 438 (actual)
- Sponsor
- Velicept Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Solabegron immediate release tablets, low dose | twice daily for 12 weeks. |
| DRUG | Solabegron immediate release tablets, high dose | twice daily for 12 weeks. |
| DRUG | Matching Placebo | twice daily for 12 weeks. |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2019-01-24
- Completion
- 2019-01-30
- First posted
- 2018-03-23
- Last updated
- 2020-03-02
Locations
86 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03475706. Inclusion in this directory is not an endorsement.