Phase
Condition
Lactose Intolerance
Colic
Gastrointestinal Diseases And Disorders
Treatment
Olorinab
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
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:
Colonoscopy (within 10 years of Visit 1 [Screening])
Flexible sigmoidoscopy and double contrast barium enema (within 5 years ofVisit 1 [Screening])
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
Connect with a study center
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama 35216
United StatesSite Not Available
Clinical Research Associates, LLC
Huntsville, Alabama 35801
United StatesSite Not Available
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona 85224
United StatesSite Not Available
Gilbert Center for Family Medicine
Gilbert, Arizona 85298
United StatesSite Not Available
Alliance Research Institute
Canoga Park, California 91304
United StatesSite Not Available
GW Research, Inc.
Chula Vista, California 91910
United StatesSite Not Available
Kindred Medical Institute for Clinical Trials, LLC
Corona, California 92879
United StatesSite Not Available
TriWest Research Associates, LLC
El Cajon, California 92020
United StatesSite Not Available
Diagnamics Inc.
Encinitas, California 92024
United StatesSite Not Available
Prime Care Clinical Research
Laguna Hills, California 92653
United StatesSite Not Available
Om Research, Attn: Heather Blunt
Lancaster, California 93534
United StatesSite Not Available
Medical Associates Research Group
San Diego, California 92123
United StatesSite Not Available
Precision Research Institute
San Diego, California 92114
United StatesSite Not Available
San Diego Gastroenterology Medical Associates (CTNx)
San Diego, California 92103
United StatesSite Not Available
Advanced Rx Clinical Research Group, Inc.
Westminster, California 92683
United StatesSite Not Available
Lynn Institute of Denver
Aurora, Colorado 80012
United StatesSite Not Available
Clinical Research of Brandon, LLC
Brandon, Florida 33511
United StatesSite Not Available
Qps Mra, Llc
South Miami, Florida 33143
United StatesSite Not Available
Precision Clinical Research, LLC.
Sunrise, Florida 33351
United StatesSite Not Available
Presicion Research Center Inc
Tampa, Florida 33603
United StatesSite Not Available
Agile Clinical Research Trials LLC
Atlanta, Georgia 30328
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
Columbus Regional Research Institute
Columbus, Georgia 31904
United StatesSite Not Available
Gastroenterology Associates of Gainesville Georgia
Gainesville, Georgia 30501
United StatesSite Not Available
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia 30328
United StatesSite Not Available
Clinical Research Atlanta
Stockbridge, Georgia 30281
United StatesSite Not Available
Advanced Clinical Research, Attn to: Owen Havey
Meridian, Idaho 83642
United StatesSite Not Available
Claude Mandel Medical Center
Chicago, Illinois 60617
United StatesSite Not Available
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois 60181
United StatesSite Not Available
MediSphere Medical Research Center, LLC
Evansville, Indiana 47714
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
WestGlenGI
Shawnee Mission, Kansas 66217
United StatesSite Not Available
CroNOLA, LLC
Houma, Louisiana 70360
United StatesSite Not Available
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana 70601
United StatesSite Not Available
Louisiana Research Center, LLC
Shreveport, Louisiana 71105
United StatesSite Not Available
Frederick Gastroenterology Associates
Frederick, Maryland 21701
United StatesSite Not Available
Flint Clinical Research, PLLC
Flint, Michigan 48503
United StatesSite Not Available
Center for Pharmaceutical Research, LLC an AMR company
Kansas City, Missouri 64114
United StatesSite Not Available
Hassman Research Institute
Berlin, New Jersey 08009
United StatesSite Not Available
Long Island Gastrointestinal Research Group LLP
Great Neck, New York 11023
United StatesSite Not Available
Clinical Research of Gastonia
Gastonia, North Carolina 28054
United StatesSite Not Available
Medication Management, LLC
Greensboro, North Carolina 27408
United StatesSite Not Available
Peters Medical Research, LLC
High Point, North Carolina 27262
United StatesSite Not Available
M3 Wake Research
Raleigh, North Carolina 27612
United StatesSite Not Available
Great Lakes Medical Research
Beachwood, Ohio 44122
United StatesSite Not Available
Rapid Medical Research, Inc.
Cleveland, Ohio 44122
United StatesSite Not Available
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United StatesSite Not Available
Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
Wadsworth, Ohio 44281
United StatesSite Not Available
Central Sooner Research
Norman, Oklahoma 73071
United StatesSite Not Available
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Lynn Institute of Tulsa
Tulsa, Oklahoma 74105
United StatesSite Not Available
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon 97301
United StatesSite Not Available
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Care Access Research, Pottsville
Pottsville, Pennsylvania 17901
United StatesSite Not Available
Clinical Trials of South Carolina
Charleston, South Carolina 29406
United StatesSite Not Available
Coastal Carolina Research Center
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
United StatesSite Not Available
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota 57049
United StatesSite Not Available
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee 37404
United StatesSite Not Available
WR-ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
Biopharma Informatic, LLC
Houston, Texas 77043
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
Research Studies at Fine Digestive Health
Irving, Texas 75039
United StatesSite Not Available
ACR Gut Whisperer
West Jordan, Utah 84088
United StatesSite Not Available
New River Valley Research Institute
Christiansburg, Virginia 24073
United StatesSite Not Available
MultiCare Institute for Research & Innovation
Tacoma, Washington 98405
United StatesSite Not Available
Exemplar Research Inc
Morgantown, West Virginia 26505
United StatesSite Not Available

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