Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Lead Sponsor:
Urovant Sciences GmbH
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 pred...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2020
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03806127
Start Date
December 31 2018
End Date
October 6 2020
Last Update
August 2 2021
Active Locations (41)
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1
Synexus Clinical Research US, Inc.-Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
2
Clinical Research Associates
Huntsville, Alabama, United States, 35801
3
Alabama Medical Group, PC
Mobile, Alabama, United States, 36693
4
Hope Research Institute
Chandler, Arizona, United States, 85224