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



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:4/6/2019
Start Date:December 31, 2018
End Date:April 2020
Contact:JP Nicandro, PharmD
Email:clinicaltrials@urovant.com
Phone:833-219-5557

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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

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).


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)
We found this trial at
34
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Indianapolis, Indiana 46254
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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Anderson, South Carolina 29621
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Chandler, Arizona 85224
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37404
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Chesterfield, Michigan 48098
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Chula Vista, California 91910
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Garland, Texas 75044
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Greenville, North Carolina 27834
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Huntsville, Alabama 35801
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Jackson, Tennessee 38305
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Jacksonville, Florida 32224
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Jacksonville, North Carolina 28546
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La Mesa, California 91942
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Long Beach, California 90822
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6001 Airport Boulevard
Mobile, Alabama 36608
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Norman, Oklahoma 73069
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Pompano Beach, Florida 33060
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San Diego, California 92114
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San Diego, California 92123
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South Ogden, Utah 84405
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Sugar Hill, Georgia 30518
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Torrance, California 90717
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West Palm Beach, Florida 33409
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