Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Olorinab; Olorinab; Olorinab; Placebo; Olorinab; Olorinab
Intervention description: Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks; Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks; Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks; Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks; Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks; Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Abdominal pain; Olorinab; APD371; Irritable bowel syndrome (IBS); IBS-C (IBS with predominant constipation); IBS-D (IBS with predominant diarrhea)

Summary:

      The purpose of this study is to determine whether olorinab is a safe and effective treatment
      for abdominal pain in participants with irritable bowel syndrome (IBS).
    

Eligibility criteria:

        Main Study Inclusion Criteria:

          -  Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or
             predominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening)

          -  Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over
             are to have had one of the following with a result that rules out causes of abdominal
             pain other than IBS:

               1. Colonoscopy (within 10 years of Visit 1 [Screening])

               2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit
                  1 [Screening])

               3. Computed tomography colonography (within 5 years of Visit 1 [Screening])

        Main Study Exclusion Criteria:

          -  Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)

          -  Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days
             prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical
             judgment of the Investigator (or designee)

          -  Any colonic or major abdominal surgery (eg, bariatric surgery [including gastric
             banding], stomach surgery, small/large bowel surgery, or abdominal large vessel
             surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For
             participants with IBS-C, a history of cholecystectomy more than 6 months prior to
             Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy,
             caesarean section, or polypectomy are allowed as long as they have occurred at least 3
             months prior to Visit 1 (Screening).

        Long-Term Extension Inclusion Criteria:

        •All participants must have completed the Main Study (including both Visit 8 [Week 12] and
        Visit 9 [Week 14])

        Long-Term Extension Exclusion Criteria:

          -  Participant meets any exclusion criteria from the Main Study at the time of assessing
             eligibility for the LTE, unless approved by the Sponsor in advance.

          -  Participant had less than 75% overall compliance with eDiary entries during the Main
             Study.

          -  Participant deviated from the prescribed dosage regimen during the Main Study (ie,
             overall study treatment compliance less than 85% or more than 115%), unless approved
             by the Sponsor in advance.