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

July 29, 2021 updated by: Urovant Sciences GmbH

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
222

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Synexus Clinical Research US, Inc.-Simon Williamson Clinic
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
      • Mobile, Alabama, United States, 36693
        • Alabama Medical Group, PC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • HOPE Research Institute
      • Chandler, Arizona, United States, 85224
        • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
      • Mesa, Arizona, United States, 85206
        • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
      • Mesa, Arizona, United States, 85213
        • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
      • Phoenix, Arizona, United States, 85020
        • Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC
    • California
      • Chula Vista, California, United States, 91910
        • GW Research Inc - ClinEdge-PPDS
      • La Mesa, California, United States, 91942
        • TriWest Research Associates, LLC
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System - NAVREF
      • Los Angeles, California, United States, 90045
        • Southern California Research Institute Medical Group, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92114
        • Desta Digestive Disease Medical Center
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut LLC
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Division of Gastroenterology
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center of Florida
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research - ClinEdge - PPDS
    • Georgia
      • Sugar Hill, Georgia, United States, 30518
        • RNA America, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46268
        • Investigators Research Group, Llc
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Mandeville Private Physician Group, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
    • Nevada
      • Henderson, Nevada, United States, 89502
        • Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC
      • Reno, Nevada, United States, 89511
        • Advanced Research Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Healthcare Center for Digestive Health
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases
      • Jacksonville, North Carolina, United States, 28546
        • East Carolina Gastroenterology
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Dayton Gastroenterology, Inc.
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc. - Anderson
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research Inc
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions PC
    • Texas
      • Garland, Texas, United States, 75044
        • DHAT Research Institute
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Plano, Texas, United States, 75093
        • Synexus Clinical Research US, Inc.-Plano
    • Utah
      • Layton, Utah, United States, 84041
        • Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice
      • South Ogden, Utah, United States, 84405
        • Advanced Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
Time Frame: Baseline; 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).
Baseline; Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
Time Frame: Week 12
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.
Week 12
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
Time Frame: Baseline; 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).
Baseline; 12 weeks
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
Time Frame: Baseline; 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).
Baseline; 12 weeks
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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)
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.
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)
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
Time Frame: Baseline; Week 12
The investigator determined whether a change was clinically meaningful.
Baseline; Week 12
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
Time Frame: Baseline; Week 12
Clinical relevance was determined by the investigator.
Baseline; Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Urovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URO-901-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Vibegron

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings