Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
- Registration Number
- NCT03806127
- Lead Sponsor
- Urovant Sciences GmbH
- 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 predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 222
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive matching placebo orally once daily for 12 weeks. Vibegron 75 mg Vibegron Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 Baseline; 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).
- Secondary Outcome Measures
Name Time Method Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks Baseline; 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).
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks Baseline; 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).
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants Week 12 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.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) 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) 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.
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 Baseline; Week 12 The investigator determined whether a change was clinically meaningful.
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 Baseline; Week 12 Clinical relevance was determined by the investigator.
Trial Locations
- Locations (40)
Mandeville Private Physician Group, LLC
🇺🇸Mandeville, Louisiana, United States
Medical Research Center of Connecticut LLC
🇺🇸Hamden, Connecticut, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Southern California Research Institute Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Investigators Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Desta Digestive Disease Medical Center
🇺🇸San Diego, California, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
VA Long Beach Healthcare System - NAVREF
🇺🇸Long Beach, California, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Alabama Medical Group, PC
🇺🇸Mobile, Alabama, United States
Synexus Clinical Research US, Inc.-Simon Williamson Clinic
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Hope Research Institute
🇺🇸Chandler, Arizona, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Florida Center For Gastroenterology
🇺🇸Largo, Florida, United States
GW Research Inc - ClinEdge-PPDS
🇺🇸Chula Vista, California, United States
Palm Beach Research - ClinEdge - PPDS
🇺🇸West Palm Beach, Florida, United States
Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
🇺🇸Phoenix, Arizona, United States
RNA America, LLC
🇺🇸Sugar Hill, Georgia, United States
Triwest Research Associates, LLC
🇺🇸La Mesa, California, United States
Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
🇺🇸Henderson, Nevada, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Synexus Clinical Research US, Inc. - Anderson
🇺🇸Anderson, South Carolina, United States
Chattanooga Medical Research Inc
🇺🇸Chattanooga, Tennessee, United States
Atrium Healthcare Center for Digestive Health
🇺🇸Charlotte, North Carolina, United States
Clinical Research Solutions PC
🇺🇸Jackson, Tennessee, United States
Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
🇺🇸Layton, Utah, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Synexus Clinical Research US, Inc.-Plano
🇺🇸Plano, Texas, United States
Advanced Research Institute
🇺🇸South Ogden, Utah, United States
Mayo Clinic - Division of Gastroenterology
🇺🇸Jacksonville, Florida, United States
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
East Carolina Gastroenterology
🇺🇸Jacksonville, North Carolina, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States