Clinical trial NCT03806127: Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: 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)
Pain
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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. 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)

Primary outcomes:
measure: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
timeFrame: Week 12
measure: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
timeFrame: Baseline; 12 weeks
measure: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
timeFrame: Baseline; 12 weeks
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: 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)
measure: Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
timeFrame: Baseline; Week 12
measure: Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synexus Clinical Research US, Inc.-Simon Williamson Clinic
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, PC
state: Alabama
city: Chandler
country: United States
facility: Hope Research Institute
state: Arizona
city: Chandler
country: United States
facility: Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
state: Arizona
city: Mesa
country: United States
facility: Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
state: Arizona
city: Mesa
country: United States
facility: Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
state: Arizona
city: Phoenix
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
state: Arizona
city: Chula Vista
country: United States
facility: GW Research Inc - ClinEdge-PPDS
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates, LLC
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System - NAVREF
state: California
city: Los Angeles
country: United States
facility: Southern California Research Institute Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Desta Digestive Disease Medical Center
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic - Division of Gastroenterology
state: Florida
city: Largo
country: United States
facility: Florida Center For Gastroenterology
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research - ClinEdge - PPDS
state: Florida
city: Sugar Hill
country: United States
facility: RNA America, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Mandeville
country: United States
facility: Mandeville Private Physician Group, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Henderson
country: United States
facility: Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
state: Nevada
city: Reno
country: United States
facility: Advanced Research Institute
state: Nevada
city: Charlotte
country: United States
facility: Atrium Healthcare Center for Digestive Health
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. - Anderson
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research Inc
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions PC
state: Tennessee
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: Synexus Clinical Research US, Inc.-Plano
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
state: Utah
city: South Ogden
country: United States
facility: Advanced Research Institute
state: Utah
Study officials:
References: