Status:
COMPLETED
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Lead Sponsor:
OrphoMed, Inc.
Collaborating Sponsors:
PPD Development, LP
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety a...
Detailed Description
The objectives of this study are to evaluate the efficacy, safety and tolerability of ORP-101 in patients with IBS-D. This is a randomized, double-blind, placebo-controlled, 3-arm, 12-week, parallel p...
Eligibility Criteria
Inclusion
- Willing and able to comply with protocol, including completion of electronic daily diary as required.
- Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria, by history, for both IBS and IBS-D.
- Has abdominal pain intensity score, and stool consistency as determined by protocol and assessed by Investigator for the week prior to randomization.
- Has not used loperamide within the 14 days prior to randomization.
- Is on a stable diet for the past 12 weeks and is not planning to change lifestyle and/or diet during study.
Exclusion
- History of clinically relevant pancreatic conditions including pancreatitis, pancreas divisum, or Sphincter of Oddi (SO) dysfunction with pancreatic manifestations.
- History of biliary pathology including acute cholecystitis within 6 months or biliary pain including post-cholecystectomy pain.
- Patients who have had biliary sphincterotomy with post-procedure persistent abnormal liver function transaminases (LFTs).
- Planned elective surgery within the next 4 months.
- 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.
- History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease).
- History of lactose intolerance uncontrolled on a lactose-free diet, or other malabsorption syndromes (e.g. fructose malabsorption).
- Dysphagia or difficulty swallowing pills.
- History of inflammatory bowel disease, celiac disease, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
- History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \> 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \> 3 months prior to screening).
- Patients \>40 years of age at high risk for colon cancer must have had a screening colonoscopy within the past 3 years prior to trial screening visit or \> 50 years of age, must have had a normal screening colonoscopy within the past 10 years prior to trial screening visit. Patients with Lynch Syndrome or Familial Polyposis are excluded from the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT04129619
Start Date
November 22 2019
End Date
October 4 2021
Last Update
March 4 2022
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
Achieve Clinical Research (Site 155)
Birmingham, Alabama, United States, 35216
2
Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)
Chandler, Arizona, United States, 85224
3
Elite Clinical Studies - Phoenix (Site 116)
Phoenix, Arizona, United States, 85018
4
Del Sol Research Management - BTC (Site 165)
Tucson, Arizona, United States, 85712