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

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ClinicalTrials.gov Identifier: NCT03806127
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Study Description
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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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Vibegron Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of IBS-D participants who are abdominal pain intensity (API) weekly responders with ≥ 40% improvement over 12 weeks [ Time Frame: 12 weeks ]
  3. Number of IBS-D participants who are API weekly responders with ≥ 50% improvement over 12 weeks [ Time Frame: 12 weeks ]
  4. Number of participants with any adverse event [ Time Frame: up to Week 15 or 21 days after last dose ]
  5. Number of participants with clinically significant clinical laboratory values [ Time Frame: up to Week 15 or 21 days after last dose ]
  6. Number of participants with clinically significant vital sign values [ Time Frame: up to Week 15 or 21 days after last dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806127


Contacts
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Contact: JP Nicandro, PharmD 833-219-5557 clinicaltrials@urovant.com

Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
More Information
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Additional Information:

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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03806127    
Other Study ID Numbers: URO-901-2001
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
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)
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases