Trial · NCT03594058
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)
NCT03594058, Phase 2, Completed, Velicept Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT03594058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03594058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT03594058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,413 participants, actual
- Lead sponsor
- Velicept Therapeutics, Inc.
- Conditions
- Overactive Bladder
- Interventions
- Solabegron modified release tablets, low dose, Solabegron modified release tablets, high dose, Matching Placebo
- First posted
- 2018-07-20
- Last updated
- 2020-03-02
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in mean number of micturitions per 24 hours at Week 12 | Micturtions will be assessed prior to randomization and at Week 12 (Visit 6). | 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. |
| Secondary | Urinary Incontinence (1) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours |
| Secondary | Urinary Incontinence (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours |
| Secondary | Urinary Incontinence (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours |
| Secondary | Urinary Incontinence (4) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours |
| Secondary | Urinary Incontinence (5) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours |
| Secondary | Micturitions (1) | Prior to Randomization (Baseline) and at Weeks 4 and 8 | Change from Baseline in mean number of micturitions per 24 hours |
| Secondary | Micturitions (2) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage change from Baseline in mean number of micturitions per 24 hours |
| Secondary | Micturitions (3) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Percentage of subjects with \< 8 micturitions per 24 hours |
| Secondary | Micturitions (4) | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | Change from Baseline in mean number of nocturnal voids per 24 hours |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22695239 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03594058
GET https://conductscience.org/api/trials/v1/NCT03594058/registered