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

NCT ID: NCT04129619

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2021-10-04

Brief Summary

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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.

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Detailed Description

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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 proof-of-concept study with 2 active arms (50 mg and 100 mg ORP-101, QD) and 1 matching placebo arm, using a responsive adaptive randomization approach. After screening, patients who qualify will enter the baseline symptom assessment period, during which they will be instructed on completion of an electronic diary for daily collection of data related to their IBS symptoms, bowel function and loperamide rescue usage (not allowed during baseline).

Patients who meet all entry criteria will be randomized to receive one of two different doses of ORP-101 tablets or placebo for 12 weeks. The study drug will be taken once daily, approximately 30 minutes prior to breakfast. Patients will return to the clinic on Days 14, 28, 56, 84 (12 weeks) and 2 weeks after dosing has completed (Day 98) for a follow-up visit.

Study subjects will include both male and female adults. Approximately 320 patients with IBS-D will be randomized to receive study drug or placebo. Randomization will be stratified by history of cholecystectomy/gallbladder agenesis.

Conditions

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Irritable Bowel Syndrome With Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ORP-101 50 mg

ORP-101 (50 mg) once daily

Group Type EXPERIMENTAL

ORP-101

Intervention Type DRUG

Oral tablet

ORP-101 100 mg

ORP-101 (100 mg), once daily

Group Type EXPERIMENTAL

ORP-101

Intervention Type DRUG

Oral tablet

Placebo

Matching placebo, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

Interventions

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ORP-101

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Other Intervention Names

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dibuprenorphine-ethyl-ether

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

OrphoMed, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Achieve Clinical Research (Site 155)

Birmingham, Alabama, United States

Site Status

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

Chandler, Arizona, United States

Site Status

Elite Clinical Studies - Phoenix (Site 116)

Phoenix, Arizona, United States

Site Status

Del Sol Research Management - BTC (Site 165)

Tucson, Arizona, United States

Site Status

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

Tucson, Arizona, United States

Site Status

Del Sol Research Management - BTC (Site 130)

Tucson, Arizona, United States

Site Status

Preferred Research Partners - ClinEdge (Site 103)

Little Rock, Arkansas, United States

Site Status

Applied Research Center (Site 158)

Little Rock, Arkansas, United States

Site Status

Connecticut Clinical Research Foundation (Site 136)

Bristol, Connecticut, United States

Site Status

Imagine Research of Palm Beach County (Site 187)

Boynton Beach, Florida, United States

Site Status

Meridien Research - Lakeland (Site 167)

Lakeland, Florida, United States

Site Status

Precision Clinical Research LLC (Site 139)

Lauderdale Lakes, Florida, United States

Site Status

Meridien Research, Maitland - Inpatient (Site 141)

Maitland, Florida, United States

Site Status

Oviedo Medical Research (Site 140)

Oviedo, Florida, United States

Site Status

Clinical Research Center of Florida (Site 186)

Pompano Beach, Florida, United States

Site Status

Meridien Research - St. Petersburg (Site 132)

St. Petersburg, Florida, United States

Site Status

Agile Clinical Research Trials, LLC (Site 163)

Atlanta, Georgia, United States

Site Status

Gastrointestinal Diseases, Inc. Research (Site 137)

Columbus, Georgia, United States

Site Status

Meridian Clinical Research (Site 169)

Savannah, Georgia, United States

Site Status

In Quest Medical Research, LLC (Site 131)

Suwanee, Georgia, United States

Site Status

GNP Research (Site 145)

Valdosta, Georgia, United States

Site Status

Northwest Clinical Trials - ClinEdge (Site 133)

Boise, Idaho, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Investigators Research Group, LLC (Site 188)

Brownsburg, Indiana, United States

Site Status

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

Evansville, Indiana, United States

Site Status

Alliance for Multispecialty Research, LLC (Site 159)

Wichita, Kansas, United States

Site Status

Beth Israel Deaconess Medical Center (Site 115)

Boston, Massachusetts, United States

Site Status

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

Richfield, Minnesota, United States

Site Status

Sundance Clinical Research (Site 175)

St Louis, Missouri, United States

Site Status

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

Omaha, Nebraska, United States

Site Status

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

Papillion, Nebraska, United States

Site Status

Jubilee Clinical Research - BTC (Site 162)

Las Vegas, Nevada, United States

Site Status

Sierra Clinical Research (Site 179)

Las Vegas, Nevada, United States

Site Status

Lovelace Scientific Resources Inc. (Site 176)

Albuquerque, New Mexico, United States

Site Status

NY Scientific (Site 153)

Brooklyn, New York, United States

Site Status

Long Island Gastrointestinal Research Group LLP (Site 107)

Great Neck, New York, United States

Site Status

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

Jamaica, New York, United States

Site Status

Mid Hudson Medical Research PLLC (Site 174)

Newburgh, New York, United States

Site Status

Upstate Clinical Research Associates LLC - ClinEdge (Site 164)

Williamsville, New York, United States

Site Status

OnSite Clinical Solutions, LLC - ClinEdge (Site 147)

Charlotte, North Carolina, United States

Site Status

OnSite Clinical Solutions, LLC - ClinEdge (Site 146)

Charlotte, North Carolina, United States

Site Status

Peters Medical Research, LLC - ClinEdge (SIte 111)

High Point, North Carolina, United States

Site Status

PMG Research of Salisbury LLC (Site 110)

Salisbury, North Carolina, United States

Site Status

PMG Research of Wilmington (Site 185)

Wilmington, North Carolina, United States

Site Status

PMG Research of Winston-Salem (Site 124)

Winston-Salem, North Carolina, United States

Site Status

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

Akron, Ohio, United States

Site Status

Hometown Urgent Care and Research (Site 150)

Cincinnati, Ohio, United States

Site Status

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

Cincinnati, Ohio, United States

Site Status

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

Columbus, Ohio, United States

Site Status

Hometown Urgent Care and Research (Site 149)

Columbus, Ohio, United States

Site Status

Remington Davis Inc (Site 144)

Columbus, Ohio, United States

Site Status

PriMed Clinical Research - ClinEdge (Site 121)

Dayton, Ohio, United States

Site Status

Hometown Urgent Care and Research (Site 151)

Dayton, Ohio, United States

Site Status

Medical Research international (Site 180)

Oklahoma City, Oklahoma, United States

Site Status

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

Philadelphia, Pennsylvania, United States

Site Status

Frontier Clinical Research, LLC (Site 171)

Uniontown, Pennsylvania, United States

Site Status

Piedmont Research Partners LLC - BTC (Site 157)

Fort Mill, South Carolina, United States

Site Status

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

Greer, South Carolina, United States

Site Status

WR-ClinSearch, LLC (Site 129)

Chattanooga, Tennessee, United States

Site Status

The Jackson Clinic PA - ClinEdge (Site 135)

Jackson, Tennessee, United States

Site Status

New Phase Research & Development (Site 181)

Knoxville, Tennessee, United States

Site Status

Benchmark Research - Austin (Site 178)

Austin, Texas, United States

Site Status

Advanced Medical Trials (SIte 142)

Georgetown, Texas, United States

Site Status

Pioneer Research Solutions (Site 125)

Houston, Texas, United States

Site Status

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

Missouri City, Texas, United States

Site Status

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

Pearland, Texas, United States

Site Status

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

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas Incorporated - ClinEdge (Site 134)

San Antonio, Texas, United States

Site Status

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

Murray, Utah, United States

Site Status

Advanced Research Institute (Site 117)

Ogden, Utah, United States

Site Status

Health Research of Hampton Roads Inc. (Site 173)

Newport News, Virginia, United States

Site Status

The Center of Gastrointestinal Health (Site 152)

Petersburg, Virginia, United States

Site Status

Northwest Clinical Research Center - ClinEdge (Site 148)

Bellevue, Washington, United States

Site Status

Exemplar Research, Inc. - Morgantown (Site 172)

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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OM-201

Identifier Type: -

Identifier Source: org_study_id

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