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

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ClinicalTrials.gov Identifier: NCT03806127
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Vibegron Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Vibegron 75 mg
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
Drug: Vibegron
oral administration
Other Names:
  • RVT-901
  • MK-4618
  • KRP-114V
  • URO-901

Placebo Comparator: Placebo
Participants will receive matching placebo orally once daily for 12 weeks.
Drug: Placebo
oral administration




Primary Outcome Measures :
  1. Number of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) participants who are abdominal pain intensity (API) weekly responders at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Global Improvement Scale (GIS) score at Week 12 for IBS-D participants, IBS with mixed episodes of diarrhea and constipation (IBS-M) participants, and all IBS participants [ Time Frame: Week 12 ]
  2. Number of participants with any adverse event [ Time Frame: up to Week 15 or 21 days after last dose ]
  3. Number of participants with clinically significant clinical laboratory values [ Time Frame: up to Week 15 or 21 days after last dose ]
  4. Number of participants with clinically significant vital sign values [ Time Frame: up to Week 15 or 21 days after last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Fecal calprotectin and serum tissue transglutaminase antibody (IgA) must be negative. (Normal complete blood cell count and C-reactive protein is required by Rome IV.)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806127


Contacts
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Contact: JP Nicandro, PharmD 833-219-5557 clinicaltrials@urovant.com

  Hide Study Locations
Locations
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United States, Alabama
Clinical Research Associates Recruiting
Huntsville, Alabama, United States, 35801
Alabama Medical Group, PC Recruiting
Mobile, Alabama, United States, 36693
United States, Arizona
Hope Research Institute Recruiting
Chandler, Arizona, United States, 85224
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC Recruiting
Chandler, Arizona, United States, 85224
Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC Recruiting
Phoenix, Arizona, United States, 85020
United States, California
GW Research Inc - ClinEdge-PPDS Recruiting
Chula Vista, California, United States, 91910
Triwest Research Associates, LLC Recruiting
La Mesa, California, United States, 91942
VA Long Beach Healthcare System - NAVREF Not yet recruiting
Long Beach, California, United States, 90822
Southern California Research Institute Medical Group, Inc. Recruiting
Los Angeles, California, United States, 90045
Desta Digestive Disease Medical Center Recruiting
San Diego, California, United States, 92114
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States, 92123
Torrance Clinical Research Recruiting
Torrance, California, United States, 90505
United States, Connecticut
Medical Research Center of Connecticut LLC Recruiting
Hamden, Connecticut, United States, 06518
United States, Florida
Mayo Clinic - Division of Gastroenterology Recruiting
Jacksonville, Florida, United States, 32224
Florida Center For Gastroenterology Recruiting
Largo, Florida, United States, 33777
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
Palm Beach Research - ClinEdge - PPDS Recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
RNA America, LLC Recruiting
Sugar Hill, Georgia, United States, 30518
United States, Indiana
Investigators Research Group, LLC Recruiting
Indianapolis, Indiana, United States, 46268
United States, Louisiana
Mandeville Private Physician Group, LLC Recruiting
Mandeville, Louisiana, United States, 70471
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan Recruiting
Chesterfield, Michigan, United States, 48047
United States, Nevada
Advanced Research Institute Recruiting
Reno, Nevada, United States, 89511
United States, North Carolina
UNC School of Medicine, Charlotte Campus Recruiting
Charlotte, North Carolina, United States, 28204
Carolina Digestive Diseases Recruiting
Greenville, North Carolina, United States, 27834
East Carolina Gastroenterology Recruiting
Jacksonville, North Carolina, United States, 28546
United States, Ohio
Dayton Gastroenterology, Inc. Recruiting
Beavercreek, Ohio, United States, 45440
Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Central Sooner Research Recruiting
Norman, Oklahoma, United States, 73071
United States, South Carolina
Synexus Clinical Research US, Inc. - Anderson Recruiting
Anderson, South Carolina, United States, 29621
United States, Tennessee
Chattanooga Medical Research Inc Recruiting
Chattanooga, Tennessee, United States, 37404
Clinical Research Solutions PC Recruiting
Jackson, Tennessee, United States, 38305
United States, Texas
MW Clinical Research Center Withdrawn
Beaumont, Texas, United States, 77701
DHAT Research Institute Recruiting
Garland, Texas, United States, 75044
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
United States, Utah
Advanced Research Institute Recruiting
South Ogden, Utah, United States, 84405
Sponsors and Collaborators
Urovant Sciences GmbH

Additional Information:
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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03806127     History of Changes
Other Study ID Numbers: URO-901-2001
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
Irritable Bowel Syndrome
Irritable Bowel Syndrome with predominantly diarrhea (IBS-D)
Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M)
Vibegron
Beta-3 adrenergic receptor (β3-AR)
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases