Back to resultsStudy to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vibegron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring 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
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)
Sites / Locations
- Synexus Clinical Research US, Inc.-Simon Williamson Clinic
- Clinical Research Associates
- Alabama Medical Group, PC
- Hope Research Institute
- Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
- Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
- Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
- Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
- GW Research Inc - ClinEdge-PPDS
- Triwest Research Associates, LLC
- VA Long Beach Healthcare System - NAVREF
- Southern California Research Institute Medical Group, Inc.
- Desta Digestive Disease Medical Center
- Medical Associates Research Group, Inc.
- Torrance Clinical Research
- Medical Research Center of Connecticut LLC
- Mayo Clinic - Division of Gastroenterology
- Florida Center For Gastroenterology
- Clinical Research Center of Florida
- Palm Beach Research - ClinEdge - PPDS
- RNA America, LLC
- Investigators Research Group, LLC
- Mandeville Private Physician Group, LLC
- Massachusetts General Hospital
- University of Michigan
- Clinical Research Institute of Michigan
- Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
- Advanced Research Institute
- Atrium Healthcare Center for Digestive Health
- Carolina Digestive Diseases
- East Carolina Gastroenterology
- Dayton Gastroenterology, Inc.
- Central Sooner Research
- Synexus Clinical Research US, Inc. - Anderson
- Chattanooga Medical Research Inc
- Clinical Research Solutions PC
- DHAT Research Institute
- University of Texas Health Science Center at Houston
- Synexus Clinical Research US, Inc.-Plano
- Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
- Advanced Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vibegron 75 mg
Placebo
Arm Description
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
Participants will receive matching placebo orally once daily for 12 weeks.
Outcomes
Primary Outcome Measures
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at 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
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
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 IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 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
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 Participants With Any Treatment-emergent Adverse Event (TEAE)
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
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
Clinical relevance was determined by the investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03806127
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urovant Sciences GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibegron 75 mg
Arm Type
Experimental
Arm Description
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Vibegron
Other Intervention Name(s)
RVT-901, MK-4618, KRP-114V, URO-901
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
Description
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).
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
Description
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.
Time Frame
Week 12
Title
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
Description
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).
Time Frame
Baseline; 12 weeks
Title
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
Description
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).
Time Frame
Baseline; 12 weeks
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
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.
Time Frame
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)
Title
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
Description
The investigator determined whether a change was clinically meaningful.
Time Frame
Baseline; Week 12
Title
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
Description
Clinical relevance was determined by the investigator.
Time Frame
Baseline; Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Synexus Clinical Research US, Inc.-Simon Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alabama Medical Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Hope Research Institute
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
GW Research Inc - ClinEdge-PPDS
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Triwest Research Associates, LLC
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
VA Long Beach Healthcare System - NAVREF
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Southern California Research Institute Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Desta Digestive Disease Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Medical Research Center of Connecticut LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Mayo Clinic - Division of Gastroenterology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Center For Gastroenterology
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Palm Beach Research - ClinEdge - PPDS
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
RNA America, LLC
City
Sugar Hill
State/Province
Georgia
ZIP/Postal Code
30518
Country
United States
Facility Name
Investigators Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
Facility Name
Mandeville Private Physician Group, LLC
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Advanced Research Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Atrium Healthcare Center for Digestive Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
East Carolina Gastroenterology
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Dayton Gastroenterology, Inc.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Chattanooga Medical Research Inc
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Clinical Research Solutions PC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Synexus Clinical Research US, Inc.-Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Advanced Research Institute
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
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