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

January 28, 2025 updated by: Arena Pharmaceuticals

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Olorinab in Subjects With Irritable Bowel Syndrome Experiencing Abdominal Pain

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Accel Research Sites - Birmingham Clinical Research Unit
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates, LLC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Gastroenterology and Hepatology Associates
      • Gilbert, Arizona, United States, 85298
        • Gilbert Center for Family Medicine
    • California
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute
      • Chula Vista, California, United States, 91910
        • GW Research, Inc.
      • Corona, California, United States, 92879
        • Kindred Medical Institute for Clinical Trials, LLC
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Encinitas, California, United States, 92024
        • Diagnamics Inc.
      • Laguna Hills, California, United States, 92653
        • Prime Care Clinical Research
      • Lancaster, California, United States, 93534
        • Om Research, Attn: Heather Blunt
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92114
        • Precision Research Institute
      • San Diego, California, United States, 92103
        • San Diego Gastroenterology Medical Associates (CTNx)
      • Westminster, California, United States, 92683
        • Advanced Rx Clinical Research Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Lynn Institute of Denver
    • Florida
      • Brandon, Florida, United States, 33511
        • Clinical Research of Brandon, LLC
      • South Miami, Florida, United States, 33143
        • Qps Mra, Llc
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research, LLC.
      • Tampa, Florida, United States, 33603
        • Presicion Research Center Inc
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Agile Clinical Research Trials LLC
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Gainesville, Georgia, United States, 30501
        • Gastroenterology Associates of Gainesville Georgia
      • Sandy Springs, Georgia, United States, 30328
        • WR-Mount Vernon Clinical Research, LLC
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research, Attn to: Owen Havey
    • Illinois
      • Chicago, Illinois, United States, 60617
        • Claude Mandel Medical Center
      • Oakbrook Terrace, Illinois, United States, 60181
        • Lemah Creek Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Shawnee Mission, Kansas, United States, 66217
        • WestGlenGI
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • CroNOLA, LLC
      • Lake Charles, Louisiana, United States, 70601
        • Clinical Trials of SWLA, LLC
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Gastroenterology Associates
    • Michigan
      • Flint, Michigan, United States, 48503
        • Flint Clinical Research, PLLC
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center for Pharmaceutical Research, LLC an AMR company
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group LLP
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia
      • Greensboro, North Carolina, United States, 27408
        • Medication Management, LLC
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research, LLC
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Great Lakes Medical Research
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Wadsworth, Ohio, United States, 44281
        • Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists, Inc.
      • Tulsa, Oklahoma, United States, 74105
        • Lynn Institute of Tulsa
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Susquehanna Research Group, LLC
      • Pottsville, Pennsylvania, United States, 17901
        • Care Access Research, Pottsville
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Meridian Clinical Research, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-Clinsearch, LLC
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Research & Medicine, PLLC
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Irving, Texas, United States, 75039
        • Research Studies at Fine Digestive Health
    • Utah
      • West Jordan, Utah, United States, 84088
        • ACR Gut Whisperer
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Exemplar Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Study Inclusion Criteria:

  • Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or predominant 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 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])

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 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).

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 of assessing eligibility for the LTE, unless approved by the Sponsor in advance.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olorinab low dose (Main Study)
Drug: Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Experimental: Olorinab medium dose (Main Study)
Drug: Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Experimental: Olorinab high dose (Main Study)
Drug: Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Placebo Comparator: Placebo (Main Study)
Drug: Placebo
Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Experimental: Olorinab (Long-Term Extension)
Participants will receive olorinab based on their treatment assignment in the Main Study.
Drug: Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371
Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Other Names:
  • APD371

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12
Time Frame: Baseline and Week 12
The APS is a single question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. The change in AAPS from Baseline at Week 12 was analyzed using a mixed-effects model repeated measures (MMRM) analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. An unstructured variance-covariance matrix was used for the MMRM analysis.
Baseline and Week 12
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 14 Weeks
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Up to 14 Weeks
LTE Period: Number of Participants With TEAEs and SAEs
Time Frame: Up to 54 Weeks
An AE was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Up to 54 Weeks
Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Time Frame: Baseline to Week 14
Blood samples were collected for the analysis of laboratory parameters including serum chemistry, hematology, coagulation, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Baseline to Week 14
LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Time Frame: Baseline to Week 54 (of LTE)
Blood samples were collected for the analysis of laboratory parameters including serum chemistry, hematology, coagulation, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Baseline to Week 54 (of LTE)
Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Time Frame: Baseline to Week 14
Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), heart rate (HR), body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.
Baseline to Week 14
LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Time Frame: Baseline to Week 54 (of LTE)
Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), HR, body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.
Baseline to Week 54 (of LTE)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12
Time Frame: Baseline and Week 12
The percentage of participants achieving a >= 30% improvement in AAPS from Baseline at Week 12 was analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by the stratification factors. Missing post-baseline AAPS data was imputed using multiple imputation (MI) under the missing at random (MAR) assumption. Participants who were randomized but did not have at least 1 post-Baseline observation were considered non-responders. A >= 30% improvement in AAPS was a reduction in AAPS of 30% or more when compared to Baseline AAPS.
Baseline and Week 12
Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks
Time Frame: Baseline and Week 12
The percentage of participants achieving a >= 30% improvement in AAPS from Baseline for at least 6 of the 12 weeks during the Treatment Period were analyzed using a CMH test stratified by the stratification factors. A >= 30% improvement in AAPS is a reduction in AAPS of 30% or more when compared to Baseline AAPS. Missing post-baseline AAPS data was imputed using MI under the MAR assumption.
Baseline and Week 12
Main Study: Percent Change From Baseline in AAPS at Week 12
Time Frame: Baseline and Week 12
The percent change in AAPS from Baseline at Week 12 was analyzed using an MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.
Baseline and Week 12
Main Study: Change From Baseline in Number of Pain-Free Days at Week 12
Time Frame: Baseline and Week 12
The change from Baseline at Week 12 in number of pain-free days per week was analyzed using a MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline pain free days as a covariate. Pain-free days were defined as days with a pain score of zero (0). Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.
Baseline and Week 12
Main Study: Maximum Concentration (Cmax) of Olorinab
Time Frame: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Cmax of Olorinab. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab
Time Frame: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Tmax of Olorinab. PK analysis was conducted using standard non-compartmental methods.
On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab
Time Frame: Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12
Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate Ctrough of Olorinab. PK analysis was conducted using standard non-compartmental methods.
Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arena Pharmaceuticals

Investigators

  • Study Director: Arena CT.gov Administrator, Arena Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD371-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Olorinab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe