Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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 180-participant average among 45 other Overactive Bladder trials with a reported enrollment target (685% higher). The trial reports 20 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03594058
The ClinicalTrials.gov registry entry for NCT03594058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,413 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 180-participant average among 45 other Overactive Bladder trials with a reported enrollment target (685% higher). The listed sponsor is Velicept Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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
Similar trials for Overactive Bladder
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.
-
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
RECRUITING · Phase 2
-
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase
COMPLETED · Phase 2
-
Bacterial Genomic Sequencing in Overactive Bladder
COMPLETED · Phase 2
-
Combined Behavioral and Drug Treatment of Overactive Bladder in Men
COMPLETED · Phase 2
-
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
RECRUITING · NA
-
Bladder Botox UTI Antibiotic Prophylaxis
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.