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NCT03594058 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)
A Phase 2 study of Overactive Bladder, sponsored by Velicept Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,413
- Enrollment target
- 20
- Study locations
NCT03594058: Completed Phase 2 study of Overactive Bladder, sponsored by Velicept Therapeutics.
NCT03594058 is a Phase 2 study of Overactive Bladder that has completed, run by Velicept Therapeutics. The registered enrollment target is 1,413 participants, above the 177-participant average among 46 other Overactive Bladder trials with a reported enrollment target (698% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594058, a Phase 2 study of Overactive Bladder, has completed, sponsored by Velicept Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,413 participants
- Enrollment target
- 20
- Study locations
Study 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 modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
Primary Outcome
Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Solabegron modified release tablets, low dose
- DRUG Solabegron modified release tablets, high dose
Study Locations (20)
California
- Velicept Investigative Site - Lincoln - Lincoln
- Velicept Investigative Site - North Hollywood - North Hollywood
- Velicept Investigative Site - Sacramento - Sacramento
- Velicept Investigative Site - San Diego - San Diego
- Velicept Investigative Site - San Diego - San Diego
- Velicept Investigative Site - Spring Valley - Spring Valley
- Velicept Investigative Site - Upland - Upland
Alabama
- Velicept Investigative Site - Birmingham - Birmingham
- Velicept Investigative Site - Birmingham - Birmingham
- Velicept Investigative Site - Guntersville - Guntersville
- Velicept Investigative Site - Saraland - Saraland
Florida
- Velicept Investigative Site - Aventura - Aventura
- Velicept Investigative Site - Doral(2) - Doral
- Velicept Investigative Site - Doral - Doral
- Velicept Investigative Site - Edgewater - Edgewater
Arizona
- Velicept Investigative Site - Tucson - Tucson
- Velicept Investigative Site - Tucson - Tucson
Colorado
- Velicept Investigative Site - Aurora - Aurora
- Velicept Investigative Site - Englewood - Englewood
Connecticut
- Velicept Investigative Site - New London - New London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,413 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 2 |
What the finished NCT03594058 record still lists
NCT03594058 is an interventional study that assigns participants to a tested intervention. Its 1,413 participants enrollment target places it among the larger protocols in the corpus, above the 177-participant average among 46 other Overactive Bladder trials with a reported enrollment target (698% higher).
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 3 interventions - of which Matching Placebo is the first listed.
NCT03594058 names 20 study sites across 6 states, led by California, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT03594058 about?
NCT03594058 is a clinical study titled "A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)". This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult fem...
What is the current status of trial NCT03594058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,413 participants. The study started on 2018-07-09. Estimated completion is 2019-05-02.
What conditions does trial NCT03594058 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT03594058?
The interventions under investigation include: Matching Placebo (DRUG), Solabegron modified release tablets, low dose (DRUG), Solabegron modified release tablets, high dose (DRUG).
Who is sponsoring clinical trial NCT03594058?
This trial is sponsored by Velicept Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03594058 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03594058's enrollment target sits among peer trials
1,413 2nd of 46 the highest of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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