IRRITABLE BOWEL SYNDROME WITH DIARRHEA CLINICAL TRIAL
Study Title:
A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ORP‑101 in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D)
Study Population:
The plan is for approximately 360 subjects with IBS-D to be randomized to receive study drug. Subjects will be stratified across treatment arms by history of cholecystectomy/gallbladder agenesis.
Inclusion Criteria:
- 1. Male or female adults between 18 and 75 years of age, inclusive.
- 2. Willingness and ability to comply with the requirements of the protocol and follow directions from the clinic staff (includes daily diary completion).
- 3. Has a diagnosis of IBS-D and meets the Rome IV Criteria, by history, for both IBS and IBS-D.
Exclusion Criteria:
- 1. History of any clinically relevant pancreatic conditions including pancreatitis, pancreas divisum, Sphincter of Oddi (SO) dysfunction with pancreatic manifestations (pain with elevated amylase or lipase or dilated pancreatic duct).
- 2. History of biliary pathology including acute cholecystitis within 6 months or biliary pain including post-cholecystectomy pain (eg, biliary obstruction, biliary stricture, SO stenosis, SO spasm or common bile duct stones or chronic biliary pain including documented or presumed biliary SO dysfunction or functional biliary pain).
- 3. Patients who have had biliary sphincterotomy with post procedure persistent abnormal LFTs.
- 4. Significant and/or severe medical illnesses such as cardiovascular, neurological, infectious, renal, hepatic or respiratory disorders that would interfere with the patient’s medical care, participation in or conduct of the study.
Duration of Treatment:
Once daily dosing for 12 weeks.
Study Duration:
Each subject will be enrolled in the study for approximately 18 weeks and study enrollment will take approximately 1 year if all 360 patients are randomized. Therefore, the clinical portion of the study will last up to approximately 18 months.