Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Launched by ARENA PHARMACEUTICALS · Aug 1, 2019

Keywords

ClinConnect Summary

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Gender

ALL

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.