Status:
TERMINATED
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Lead Sponsor:
Arena Pharmaceuticals
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Inclusion
- Main Study
- 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:
- Colonoscopy (within 10 years of Visit 1 \[Screening\])
- Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 \[Screening\])
- Computed tomography colonography (within 5 years of Visit 1 \[Screening\])
- Main Study
Exclusion
- 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
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT04043455
Start Date
July 24 2019
End Date
April 29 2021
Last Update
January 30 2025
Active Locations (69)
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1
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
2
Clinical Research Associates, LLC
Huntsville, Alabama, United States, 35801
3
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States, 85224
4
Gilbert Center for Family Medicine
Gilbert, Arizona, United States, 85298