Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
NCT ID: NCT04043455
Last Updated: 2025-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
273 participants
INTERVENTIONAL
2019-07-24
2021-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olorinab low dose (Main Study)
Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab medium dose (Main Study)
Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab high dose (Main Study)
Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Placebo (Main Study)
Placebo
Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab (Long-Term Extension)
Participants will receive olorinab based on their treatment assignment in the Main Study.
Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Interventions
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Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Placebo
Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than IBS:
1. Colonoscopy (within 10 years of Visit 1 \[Screening\])
2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 \[Screening\])
3. Computed tomography colonography (within 5 years of Visit 1 \[Screening\])
•All participants must have completed the Main Study (including both Visit 8 \[Week 12\] and Visit 9 \[Week 14\])
Exclusion Criteria
* Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
* Any colonic or major abdominal surgery (eg, bariatric surgery \[including gastric banding\], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For participants with IBS-C, a history of cholecystectomy more than 6 months prior to 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).
* Participant had less than 75% overall compliance with eDiary entries during the Main Study.
* Participant deviated from the prescribed dosage regimen during the Main Study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the Sponsor in advance.
18 Years
70 Years
ALL
No
Sponsors
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Arena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Arena CT.gov Administrator
Role: STUDY_DIRECTOR
Arena Pharmaceuticals
Locations
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Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Clinical Research Associates, LLC
Huntsville, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States
Gilbert Center for Family Medicine
Gilbert, Arizona, United States
Alliance Research Institute
Canoga Park, California, United States
GW Research, Inc.
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Diagnamics Inc.
Encinitas, California, United States
Prime Care Clinical Research
Laguna Hills, California, United States
Om Research, Attn: Heather Blunt
Lancaster, California, United States
San Diego Gastroenterology Medical Associates (CTNx)
San Diego, California, United States
Precision Research Institute
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Advanced Rx Clinical Research Group, Inc.
Westminster, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
Clinical Research of Brandon, LLC
Brandon, Florida, United States
Qps Mra, Llc
South Miami, Florida, United States
Precision Clinical Research, LLC.
Sunrise, Florida, United States
Presicion Research Center Inc
Tampa, Florida, United States
Agile Clinical Research Trials LLC
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Gastroenterology Associates of Gainesville Georgia
Gainesville, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Advanced Clinical Research, Attn to: Owen Havey
Meridian, Idaho, United States
Claude Mandel Medical Center
Chicago, Illinois, United States
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
WestGlenGI
Shawnee Mission, Kansas, United States
CroNOLA, LLC
Houma, Louisiana, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Frederick Gastroenterology Associates
Frederick, Maryland, United States
Flint Clinical Research, PLLC
Flint, Michigan, United States
Center for Pharmaceutical Research, LLC an AMR company
Kansas City, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
M3 Wake Research
Raleigh, North Carolina, United States
Great Lakes Medical Research
Beachwood, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
Wadsworth, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
Care Access Research, Pottsville
Pottsville, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, United States
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Research Studies at Fine Digestive Health
Irving, Texas, United States
ACR Gut Whisperer
West Jordan, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Exemplar Research Inc
Morgantown, West Virginia, United States
Countries
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References
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Chang L, Cash BD, Lembo A, Kunkel DC, English BA, Lindstrom B, Gu G, Skare S, Gilder K, Turner S, Cataldi F, Lipkis D, Tack J. Efficacy and safety of olorinab, a full agonist of the cannabinoid receptor 2, for the treatment of abdominal pain in patients with irritable bowel syndrome: Results from a phase 2b randomized placebo-controlled trial (CAPTIVATE). Neurogastroenterol Motil. 2023 May;35(5):e14539. doi: 10.1111/nmo.14539. Epub 2023 Feb 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APD371-202
Identifier Type: -
Identifier Source: org_study_id
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