Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Last updated: January 28, 2025
Sponsor: Arena Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

Olorinab

Placebo

Clinical Study ID

NCT04043455
APD371-202
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).

Eligibility Criteria

Inclusion

Main Study Inclusion Criteria:

  • Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) orpredominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening)

  • Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and overare to have had one of the following with a result that rules out causes ofabdominal pain other than IBS:

  1. Colonoscopy (within 10 years of Visit 1 [Screening])

  2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years ofVisit 1 [Screening])

  3. Computed tomography colonography (within 5 years of Visit 1 [Screening])

Exclusion

Main Study Exclusion Criteria:

  • Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)

  • Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30days prior to Visit 1 (Screening) that may confound efficacy assessments in theclinical judgment of the Investigator (or designee)

  • Any colonic or major abdominal surgery (eg, bariatric surgery [including gastricbanding], stomach surgery, small/large bowel surgery, or abdominal large vesselsurgery). History of cholecystectomy is exclusionary for participants with IBS-D.For participants with IBS-C, a history of cholecystectomy more than 6 months priorto Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy,caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Visit 1 (Screening).

Long-Term Extension Inclusion Criteria:

•All participants must have completed the Main Study (including both Visit 8 [Week 12] and Visit 9 [Week 14])

Long-Term Extension Exclusion Criteria:

  • Participant meets any exclusion criteria from the Main Study at the time ofassessing eligibility for the LTE, unless approved by the Sponsor in advance.

  • Participant had less than 75% overall compliance with eDiary entries during the MainStudy.

  • Participant deviated from the prescribed dosage regimen during the Main Study (ie,overall study treatment compliance less than 85% or more than 115%), unless approvedby the Sponsor in advance.

Study Design

Total Participants: 273
Treatment Group(s): 2
Primary Treatment: Olorinab
Phase: 2
Study Start date:
July 24, 2019
Estimated Completion Date:
April 29, 2021

Connect with a study center

  • Accel Research Sites - Birmingham Clinical Research Unit

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Clinical Research Associates, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • East Valley Gastroenterology and Hepatology Associates

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Gilbert Center for Family Medicine

    Gilbert, Arizona 85298
    United States

    Site Not Available

  • Alliance Research Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • GW Research, Inc.

    Chula Vista, California 91910
    United States

    Site Not Available

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California 92879
    United States

    Site Not Available

  • TriWest Research Associates, LLC

    El Cajon, California 92020
    United States

    Site Not Available

  • Diagnamics Inc.

    Encinitas, California 92024
    United States

    Site Not Available

  • Prime Care Clinical Research

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Om Research, Attn: Heather Blunt

    Lancaster, California 93534
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Site Not Available

  • Precision Research Institute

    San Diego, California 92114
    United States

    Site Not Available

  • San Diego Gastroenterology Medical Associates (CTNx)

    San Diego, California 92103
    United States

    Site Not Available

  • Advanced Rx Clinical Research Group, Inc.

    Westminster, California 92683
    United States

    Site Not Available

  • Lynn Institute of Denver

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Clinical Research of Brandon, LLC

    Brandon, Florida 33511
    United States

    Site Not Available

  • Qps Mra, Llc

    South Miami, Florida 33143
    United States

    Site Not Available

  • Precision Clinical Research, LLC.

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Presicion Research Center Inc

    Tampa, Florida 33603
    United States

    Site Not Available

  • Agile Clinical Research Trials LLC

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Columbus Regional Research Institute

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Gastroenterology Associates of Gainesville Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Advanced Clinical Research, Attn to: Owen Havey

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Claude Mandel Medical Center

    Chicago, Illinois 60617
    United States

    Site Not Available

  • Lemah Creek Clinical Research

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • WestGlenGI

    Shawnee Mission, Kansas 66217
    United States

    Site Not Available

  • CroNOLA, LLC

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Frederick Gastroenterology Associates

    Frederick, Maryland 21701
    United States

    Site Not Available

  • Flint Clinical Research, PLLC

    Flint, Michigan 48503
    United States

    Site Not Available

  • Center for Pharmaceutical Research, LLC an AMR company

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York 11023
    United States

    Site Not Available

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Medication Management, LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Peters Medical Research, LLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • M3 Wake Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Great Lakes Medical Research

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Rapid Medical Research, Inc.

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research

    Wadsworth, Ohio 44281
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma 74105
    United States

    Site Not Available

  • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

    Salem, Oregon 97301
    United States

    Site Not Available

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Care Access Research, Pottsville

    Pottsville, Pennsylvania 17901
    United States

    Site Not Available

  • Clinical Trials of South Carolina

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Coastal Carolina Research Center

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Dakota Dunes, South Dakota 57049
    United States

    Site Not Available

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • Research Studies at Fine Digestive Health

    Irving, Texas 75039
    United States

    Site Not Available

  • ACR Gut Whisperer

    West Jordan, Utah 84088
    United States

    Site Not Available

  • New River Valley Research Institute

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Exemplar Research Inc

    Morgantown, West Virginia 26505
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.