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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806127
• Other study ID #: URO-901-2001
• Status: Completed
• Phase: Phase 2
• Start date: December 31, 2018
• Est. completion date: October 6, 2020

Study information

• Verified date: July 2021
• Source: Urovant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 6, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Vibegron
oral administration
• Placebo
oral administration

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc. - Anderson	Anderson	South Carolina
United States	University of Michigan	Ann Arbor	Michigan
United States	Dayton Gastroenterology, Inc.	Beavercreek	Ohio
United States	Synexus Clinical Research US, Inc.-Simon Williamson Clinic	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hope Research Institute	Chandler	Arizona
United States	Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC	Chandler	Arizona
United States	Atrium Healthcare Center for Digestive Health	Charlotte	North Carolina
United States	Chattanooga Medical Research Inc	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	GW Research Inc - ClinEdge-PPDS	Chula Vista	California
United States	DHAT Research Institute	Garland	Texas
United States	Carolina Digestive Diseases	Greenville	North Carolina
United States	Medical Research Center of Connecticut LLC	Hamden	Connecticut
United States	Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC	Henderson	Nevada
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Clinical Research Associates	Huntsville	Alabama
United States	Investigators Research Group, LLC	Indianapolis	Indiana
United States	Clinical Research Solutions PC	Jackson	Tennessee
United States	East Carolina Gastroenterology	Jacksonville	North Carolina
United States	Mayo Clinic - Division of Gastroenterology	Jacksonville	Florida
United States	Triwest Research Associates, LLC	La Mesa	California
United States	Florida Center For Gastroenterology	Largo	Florida
United States	Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice	Layton	Utah
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	Mandeville Private Physician Group, LLC	Mandeville	Louisiana
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	Alabama Medical Group, PC	Mobile	Alabama
United States	Central Sooner Research	Norman	Oklahoma
United States	Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc.-Plano	Plano	Texas
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Advanced Research Institute	Reno	Nevada
United States	Desta Digestive Disease Medical Center	San Diego	California
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	Advanced Research Institute	South Ogden	Utah
United States	RNA America, LLC	Sugar Hill	Georgia
United States	Torrance Clinical Research	Torrance	California
United States	Palm Beach Research - ClinEdge - PPDS	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urovant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12	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).	Baseline; Week 12
Secondary	Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants	Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.	Week 12
Secondary	Number of IBS-D Participants Who Were API Weekly Responders With = 40% Improvement Over 12 Weeks	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 40% 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).	Baseline; 12 weeks
Secondary	Number of IBS-D Participants Who Were API Weekly Responders With = 50% Improvement Over 12 Weeks	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 50% 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).	Baseline; 12 weeks
Secondary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.	from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)
Secondary	Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12	The investigator determined whether a change was clinically meaningful.	Baseline; Week 12
Secondary	Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12	Clinical relevance was determined by the investigator.	Baseline; Week 12