Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
NCT ID: NCT03806127
Last Updated: 2021-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
222 participants
INTERVENTIONAL
2018-12-31
2020-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vibegron 75 mg
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
Vibegron
oral administration
Placebo
Participants will receive matching placebo orally once daily for 12 weeks.
Placebo
oral administration
Interventions
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Vibegron
oral administration
Placebo
oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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)
18 Years
70 Years
FEMALE
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
Henderson, Nevada, United States
Advanced Research Institute
Reno, Nevada, United States
Atrium Healthcare Center for Digestive Health
Charlotte, North Carolina, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, United States
Clinical Research Solutions PC
Jackson, Tennessee, United States
DHAT Research Institute
Garland, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Synexus Clinical Research US, Inc.-Plano
Plano, Texas, United States
Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
Layton, Utah, United States
Advanced Research Institute
South Ogden, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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URO-901-2001
Identifier Type: -
Identifier Source: org_study_id
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