Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806127
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date July 27, 2020
Actual Study Start Date  ICMJE December 31, 2018
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Number of Global Improvement Scale (GIS) responders at Week 12 for all IBS participants, including IBS-D and IBS with mixed episodes of diarrhea and constipation (IBS-M) participants [ Time Frame: Week 12 ]
  • Number of IBS-D participants who are abdominal pain intensity (API) weekly responders with ≥ 40% improvement over 12 weeks [ Time Frame: 12 weeks ]
  • Number of IBS-D participants who are API weekly responders with ≥ 50% improvement over 12 weeks [ Time Frame: 12 weeks ]
  • Number of participants with any adverse event [ Time Frame: up to Week 15 or 21 days after last dose ]
  • Number of participants with clinically significant clinical laboratory values [ Time Frame: up to Week 15 or 21 days after last dose ]
  • Number of participants with clinically significant vital sign values [ Time Frame: up to Week 15 or 21 days after last dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • 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 ]
  • Number of participants with any adverse event [ Time Frame: up to Week 15 or 21 days after last dose ]
  • Number of participants with clinically significant clinical laboratory values [ Time Frame: up to Week 15 or 21 days after last dose ]
  • Number of participants with clinically significant vital sign values [ Time Frame: up to Week 15 or 21 days after last dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Vibegron
    oral administration
    Other Names:
    • RVT-901
    • MK-4618
    • KRP-114V
    • URO-901
  • Drug: Placebo
    oral administration
Study Arms  ICMJE
  • Experimental: Vibegron 75 mg
    Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
    Intervention: Drug: Vibegron
  • Placebo Comparator: Placebo
    Participants will receive matching placebo orally once daily for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806127
Other Study ID Numbers  ICMJE URO-901-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Urovant Sciences GmbH
Study Sponsor  ICMJE Urovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Urovant Sciences GmbH
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP