Trials / Completed
CompletedNCT03806127
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 222 (actual)
- Sponsor
- Urovant Sciences GmbH · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vibegron | oral administration |
| DRUG | Placebo | oral administration |
Timeline
- Start date
- 2018-12-31
- Primary completion
- 2020-09-25
- Completion
- 2020-10-06
- First posted
- 2019-01-16
- Last updated
- 2021-08-02
- Results posted
- 2021-07-30
Locations
41 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03806127. Inclusion in this directory is not an endorsement.