Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03806127 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
A Phase 2 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT03806127: Completed Phase 2 study, sponsored by Urovant Sciences.
NCT03806127 is a Phase 2 study that has completed, run by Urovant Sciences. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03806127, a Phase 2 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study 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).
Primary Outcome
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Interventions
- DRUG Placebo
- DRUG Vibegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2020-10-06 |
| Phase | Phase 2 |
What the finished NCT03806127 record still lists
NCT03806127 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03806127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03806127 about?
NCT03806127 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome". 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).
What is the current status of trial NCT03806127?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2018-12-31. Estimated completion is 2020-10-06.
What interventions are being tested in trial NCT03806127?
The interventions under investigation include: Placebo (DRUG), Vibegron (DRUG).
Who is sponsoring clinical trial NCT03806127?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03806127's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
- NCT05605574 · 222 participants · NA
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI