Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arena Pharmaceuticals
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \[Screening\])
All participants must have completed the Main Study (including both Visit 8 \[Week 12\] and Visit 9 \[Week 14\])
You may not be if
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).
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.
Clareo Health | Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
