Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Vibegron; Placebo
Intervention description: oral administration; oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
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

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).
    

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)