Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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).

Key facts

Study ID

NCT03806127

Run by

Urovant Sciences GmbH

People needed

222

Starts

2018-12-31

Expected to finish

2020-10-06

Last updated by the study team

2021-08-02

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
• Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
• Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.

You may not qualify if…

• Diagnosis of IBS-C or IBS-U per Rome IV criteria
• History of chronic idiopathic constipation or functional constipation
• Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
• History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
• Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
• Planned gastrointestinal or abdominal surgery within the next 6 months
• Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
• Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)

Where it is running

• Synexus Clinical Research US, Inc.-Simon Williamson Clinic — Birmingham, Alabama, United States
• Clinical Research Associates — Huntsville, Alabama, United States
• Alabama Medical Group, PC — Mobile, Alabama, United States
• Hope Research Institute — Chandler, Arizona, United States
• Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC — Mesa, Arizona, United States
• Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC — Phoenix, Arizona, United States
• GW Research Inc - ClinEdge-PPDS — Chula Vista, California, United States
• Triwest Research Associates, LLC — La Mesa, California, United States
• VA Long Beach Healthcare System - NAVREF — Long Beach, California, United States
• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Desta Digestive Disease Medical Center — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Medical Research Center of Connecticut LLC — Hamden, Connecticut, United States
• Mayo Clinic - Division of Gastroenterology — Jacksonville, Florida, United States
• Florida Center For Gastroenterology — Largo, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Palm Beach Research - ClinEdge - PPDS — West Palm Beach, Florida, United States
• RNA America, LLC — Sugar Hill, Georgia, United States
• Investigators Research Group, LLC — Indianapolis, Indiana, United States
• Mandeville Private Physician Group, LLC — Mandeville, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.