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 |
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Recruitment Status :
Recruiting
First Posted : January 16, 2019
Last Update Posted : August 28, 2019
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Sponsor:
Urovant Sciences GmbH
Information provided by (Responsible Party):
Urovant Sciences GmbH
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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 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 : | March 2020 |
| Estimated Study Completion Date : | April 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vibegron 75 mg
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
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Drug: Vibegron
oral administration
Other Names:
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Placebo Comparator: Placebo
Participants will receive matching placebo orally once daily for 12 weeks.
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Drug: Placebo
oral administration |
Primary Outcome Measures :
- 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 :
- 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 ]
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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. Fecal calprotectin and serum tissue transglutaminase antibody (IgA) must be negative. (Normal complete blood cell count and C-reactive protein is required by Rome IV.)
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)
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
| Contact: JP Nicandro, PharmD | 833-219-5557 | clinicaltrials@urovant.com |
Locations
Show 37 study locations
Sponsors and Collaborators
Urovant Sciences GmbH
Additional Information:
| 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: | August 28, 2019 |
| Last Verified: | August 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Urovant Sciences GmbH:
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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 |