A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Diarrhea

In brief

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 and tolerability of ORP-101 in patients with IBS-D.

Key facts

Study ID

NCT04129619

Run by

OrphoMed, Inc.

People needed

321

Starts

2019-11-22

Expected to finish

2021-10-04

Last updated by the study team

2022-03-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123) — Chandler, Arizona, United States
• Elite Clinical Studies - Phoenix (Site 116) — Phoenix, Arizona, United States
• Del Sol Research Management - BTC (Site 165) — Tucson, Arizona, United States
• Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118) — Tucson, Arizona, United States
• Del Sol Research Management - BTC (Site 130) — Tucson, Arizona, United States
• Preferred Research Partners - ClinEdge (Site 103) — Little Rock, Arkansas, United States
• Applied Research Center (Site 158) — Little Rock, Arkansas, United States
• Connecticut Clinical Research Foundation (Site 136) — Bristol, Connecticut, United States
• Imagine Research of Palm Beach County (Site 187) — Boynton Beach, Florida, United States
• Meridien Research - Lakeland (Site 167) — Lakeland, Florida, United States
• Precision Clinical Research LLC (Site 139) — Lauderdale Lakes, Florida, United States
• Meridien Research, Maitland - Inpatient (Site 141) — Maitland, Florida, United States
• Oviedo Medical Research (Site 140) — Oviedo, Florida, United States
• Clinical Research Center of Florida (Site 186) — Pompano Beach, Florida, United States
• Meridien Research - St. Petersburg (Site 132) — St. Petersburg, Florida, United States
• Agile Clinical Research Trials, LLC (Site 163) — Atlanta, Georgia, United States
• Gastrointestinal Diseases, Inc. Research (Site 137) — Columbus, Georgia, United States
• Meridian Clinical Research (Site 169) — Savannah, Georgia, United States
• In Quest Medical Research, LLC (Site 131) — Suwanee, Georgia, United States
• GNP Research (Site 145) — Valdosta, Georgia, United States
• Northwest Clinical Trials - ClinEdge (Site 133) — Boise, Idaho, United States
• Synexus Clinical Research US, Inc. - Chicago (Site 120) — Chicago, Illinois, United States
• Investigators Research Group, LLC (Site 188) — Brownsburg, Indiana, United States
• Synexus Clinical Research US, Inc. - Allaw (Site 102) — Evansville, Indiana, United States
• Achieve Clinical Research (Site 155) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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