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

NCT04129619 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: OM-201
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 74

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

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

Irritable Bowel Syndrome; IBS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores

  Composite responders are defined as participants who met the daily response criteria for at least 50% of the days with diary entries over the 12-week interval. A participant must meet both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Average of daily stool consistency response for all reported bowel movements on the specific day: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.

  Week 12

Secondary Outcomes (9)

• Percentage of Participants Who Are Responders in Daily Worst Abdominal Pain Scores

  Week 12

• Percentage of Participants Who Are Responders in Daily Stool Consistency Scores

  Baseline to Week 12

• Percentage of Participants Who are Responders in IBS Global Symptom Scores

  Week 12

• Percentage of Participants Who are Responders in IBS Adequate Relief Scores

  Week 12

• Percentage of Participants Who Are Modified Composite Responders Based on Responder Endpoints

  Week 12

Study Arms (3)

ORP-101 50 mg

EXPERIMENTAL

ORP-101 (50 mg) once daily

Drug: ORP-101

ORP-101 100 mg

EXPERIMENTAL

ORP-101 (100 mg), once daily

Drug: ORP-101

Placebo

PLACEBO COMPARATOR

Matching placebo, once daily

Drug: Placebo

Interventions

ORP-101 DRUG

Oral tablet

Also known as: dibuprenorphine-ethyl-ether

ORP-101 100 mg; ORP-101 50 mg

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• OrphoMed, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (74)

Achieve Clinical Research (Site 155)

Birmingham, Alabama, 35216, United States

Location

Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)

Chandler, Arizona, 85224, United States

Location

Elite Clinical Studies - Phoenix (Site 116)

Phoenix, Arizona, 85018, United States

Location

Del Sol Research Management - BTC (Site 165)

Tucson, Arizona, 85712, United States

Location

Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118)

Tucson, Arizona, 85741, United States

Location

Del Sol Research Management - BTC (Site 130)

Tucson, Arizona, 85745, United States

Location

Preferred Research Partners - ClinEdge (Site 103)

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center (Site 158)

Little Rock, Arkansas, 72212, United States

Location

Connecticut Clinical Research Foundation (Site 136)

Bristol, Connecticut, 06010, United States

Location

Imagine Research of Palm Beach County (Site 187)

Boynton Beach, Florida, 33435, United States

Location

Meridien Research - Lakeland (Site 167)

Lakeland, Florida, 33803, United States

Location

Precision Clinical Research LLC (Site 139)

Lauderdale Lakes, Florida, 33319, United States

Location

Meridien Research, Maitland - Inpatient (Site 141)

Maitland, Florida, 32751, United States

Location

Oviedo Medical Research (Site 140)

Oviedo, Florida, 32765, United States

Location

Clinical Research Center of Florida (Site 186)

Pompano Beach, Florida, 33060, United States

Location

Meridien Research - St. Petersburg (Site 132)

St. Petersburg, Florida, 33709, United States

Location

Agile Clinical Research Trials, LLC (Site 163)

Atlanta, Georgia, 30328, United States

Location

Gastrointestinal Diseases, Inc. Research (Site 137)

Columbus, Georgia, 31904, United States

Location

Meridian Clinical Research (Site 169)

Savannah, Georgia, 31406, United States

Location

In Quest Medical Research, LLC (Site 131)

Suwanee, Georgia, 30024, United States

Location

GNP Research (Site 145)

Valdosta, Georgia, 31605, United States

Location

Northwest Clinical Trials - ClinEdge (Site 133)

Boise, Idaho, 83704, United States

Location

Synexus Clinical Research US, Inc. - Chicago (Site 120)

Chicago, Illinois, 60602, United States

Location

Investigators Research Group, LLC (Site 188)

Brownsburg, Indiana, 46112, United States

Location

Synexus Clinical Research US, Inc. - Allaw (Site 102)

Evansville, Indiana, 47714, United States

Location

Alliance for Multispecialty Research, LLC (Site 159)

Wichita, Kansas, 67207, United States

Location

Beth Israel Deaconess Medical Center (Site 115)

Boston, Massachusetts, 02215, United States

Location

AES-DRS-Synexus Clinical Research US, Inc.-Minneapolis (site 114)

Richfield, Minnesota, 55423, United States

Location

Sundance Clinical Research (Site 175)

St Louis, Missouri, 63141, United States

Location

Synexus Clinical Research US, Inc. - Omaha (Site 113)

Omaha, Nebraska, 68144, United States

Location

Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126)

Papillion, Nebraska, 68046, United States

Location

Jubilee Clinical Research - BTC (Site 162)

Las Vegas, Nevada, 89106, United States

Location

Sierra Clinical Research (Site 179)

Las Vegas, Nevada, 89106, United States

Location

Lovelace Scientific Resources Inc. (Site 176)

Albuquerque, New Mexico, 87108, United States

Location

NY Scientific (Site 153)

Brooklyn, New York, 11235, United States

Location

Long Island Gastrointestinal Research Group LLP (Site 107)

Great Neck, New York, 11023, United States

Location

Synexus Clinical Research US, Inc. - Queens (Site 119)

Jamaica, New York, 11432, United States

Location

Mid Hudson Medical Research PLLC (Site 174)

Newburgh, New York, 12553, United States

Location

Upstate Clinical Research Associates LLC - ClinEdge (Site 164)

Williamsville, New York, 14221, United States

Location

OnSite Clinical Solutions, LLC - ClinEdge (Site 147)

Charlotte, North Carolina, 28210, United States

Location

OnSite Clinical Solutions, LLC - ClinEdge (Site 146)

Charlotte, North Carolina, 28277, United States

Location

Peters Medical Research, LLC - ClinEdge (SIte 111)

High Point, North Carolina, 27262, United States

Location

PMG Research of Salisbury LLC (Site 110)

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington (Site 185)

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem (Site 124)

Winston-Salem, North Carolina, 27103, United States

Location

Synexus Clinical Research US, Inc. - Akron (Site 122)

Akron, Ohio, 44311, United States

Location

Hometown Urgent Care and Research (Site 150)

Cincinnati, Ohio, 45215, United States

Location

Synexus Clinical Research US, Inc. - Cincinnati (Site 127)

Cincinnati, Ohio, 45236, United States

Location

Synexus Clinical Research US, Inc. - Columbus (Site 108)

Columbus, Ohio, 43212, United States

Location

Hometown Urgent Care and Research (Site 149)

Columbus, Ohio, 43214, United States

Location

Remington Davis Inc (Site 144)

Columbus, Ohio, 43215, United States

Location

PriMed Clinical Research - ClinEdge (Site 121)

Dayton, Ohio, 45419, United States

Location

Hometown Urgent Care and Research (Site 151)

Dayton, Ohio, 45424, United States

Location

Medical Research international (Site 180)

Oklahoma City, Oklahoma, 73109, United States

Location

Tristar Clinical Investigations, P.C. (Site 168)

Philadelphia, Pennsylvania, 19114, United States

Location

Frontier Clinical Research, LLC (Site 171)

Uniontown, Pennsylvania, 15401, United States

Location

Piedmont Research Partners LLC - BTC (Site 157)

Fort Mill, South Carolina, 29707, United States

Location

Synexus clinical Research US, Inc. - Greer (Site 105)

Greer, South Carolina, 29651, United States

Location

WR-ClinSearch, LLC (Site 129)

Chattanooga, Tennessee, 37421, United States

Location

The Jackson Clinic PA - ClinEdge (Site 135)

Jackson, Tennessee, 38305, United States

Location

New Phase Research & Development (Site 181)

Knoxville, Tennessee, 37909, United States

Location

Benchmark Research - Austin (Site 178)

Austin, Texas, 78704, United States

Location

Advanced Medical Trials (SIte 142)

Georgetown, Texas, 78628, United States

Location

Pioneer Research Solutions (Site 125)

Houston, Texas, 77099, United States

Location

Synergy Group US, LLC - Missouri City - Hunt (Site 156)

Missouri City, Texas, 77459, United States

Location

DM Clinical Research - LinQ Research - ERN (Site 109)

Pearland, Texas, 77584, United States

Location

Synexus Clinical Research US, Inc. - San Antonio (Site 112)

San Antonio, Texas, 48229, United States

Location

Clinical Trials of Texas Incorporated - ClinEdge (Site 134)

San Antonio, Texas, 78229, United States

Location

Synexus Clinical Research US, Inc. - Salt Lake City (Site 101)

Murray, Utah, 84123, United States

Location

Advanced Research Institute (Site 117)

Ogden, Utah, 84405, United States

Location

Health Research of Hampton Roads Inc. (Site 173)

Newport News, Virginia, 23606, United States

Location

The Center of Gastrointestinal Health (Site 152)

Petersburg, Virginia, 23805, United States

Location

Northwest Clinical Research Center - ClinEdge (Site 148)

Bellevue, Washington, 98007, United States

Location

Exemplar Research, Inc. - Morgantown (Site 172)

Morgantown, West Virginia, 26505, United States

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: November 22, 2019
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (74)