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Irritable Bowel SyndromePhase 2CAPTIVATENCT04043455

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

A Phase 2 study testing Olorinab in people with Irritable Bowel Syndrome, run by Arena Pharmaceuticals at 69 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Olorinab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
273 participants
Where
69 sitesUnited States
Study dates
24 Jul 2019to 29 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Agile Clinical Research Trials LLC

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Great Lakes Medical Research

    Beachwood, Ohio, 44122

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Accel Research Sites - Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216

  • Clinical Research of Brandon, LLC

    Brandon, Florida, 33511

  • Alliance Research Institute

    Canoga Park, California, 91304

  • East Valley Gastroenterology and Hepatology Associates

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Claude Mandel Medical Center

    Chicago, Illinois, 60617

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc.

    Chula Vista, California, 91910

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Meridian Clinical Research, LLC

    Dakota Dunes, South Dakota, 57049

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Diagnamics Inc.

    Encinitas, California, 92024

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Flint Clinical Research, PLLC

    Flint, Michigan, 48503

  • Frederick Gastroenterology Associates

    Frederick, Maryland, 21701

  • Gastroenterology Associates of Gainesville Georgia

    Gainesville, Georgia, 30501

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Gilbert Center for Family Medicine

    Gilbert, Arizona, 85298

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York, 11023

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262

  • CroNOLA, LLC

    Houma, Louisiana, 70360

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Clinical Trial Network

    Houston, Texas, 77074

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Research Studies at Fine Digestive Health

    Irving, Texas, 75039

  • Center for Pharmaceutical Research, LLC an AMR company

    Kansas City, Missouri, 64114

  • Prime Care Clinical Research

    Laguna Hills, California, 92653

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • Om Research, Attn: Heather Blunt

    Lancaster, California, 93534

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Advanced Clinical Research, Attn to: Owen Havey

    Meridian, Idaho, 83642

  • Exemplar Research Inc

    Morgantown, West Virginia, 26505

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Lemah Creek Clinical Research

    Oakbrook Terrace, Illinois, 60181

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Care Access Research, Pottsville

    Pottsville, Pennsylvania, 17901

  • M3 Wake Research

    Raleigh, North Carolina, 27612

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

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

    Salem, Oregon, 97301

  • San Diego Gastroenterology Medical Associates (CTNx)

    San Diego, California, 92103

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • WestGlenGI

    Shawnee Mission, Kansas, 66217

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Qps Mra, Llc

    South Miami, Florida, 33143

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Precision Clinical Research, LLC.

    Sunrise, Florida, 33351

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Presicion Research Center Inc

    Tampa, Florida, 33603

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74105

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

    Wadsworth, Ohio, 44281

  • ACR Gut Whisperer

    West Jordan, Utah, 84088

  • Advanced Rx Clinical Research Group, Inc.

    Westminster, California, 92683

Other trials in United States

About this study

Official title: 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).

Being tested
Olorinab, Placebo
Keywords
Abdominal pain, Olorinab, APD371, Irritable bowel syndrome (IBS), IBS-C (IBS with predominant constipation), IBS-D (IBS with predominant diarrhea)
Medical subject headings
Irritable Bowel Syndrome, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlorinabDrug

    Also called APD371

    Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks

  • OlorinabDrug

    Also called APD371

    Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks

  • OlorinabDrug

    Also called APD371

    Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks

  • PlaceboDrug

    Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks

  • OlorinabDrug

    Also called APD371

    Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks

  • OlorinabDrug

    Also called APD371

    Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks

Study groups in NCT04043455
Study groupRoleWhat they receive
Olorinab low dose (Main Study)ExperimentalNot described
Receives: Drug: Olorinab
Olorinab medium dose (Main Study)ExperimentalNot described
Receives: Drug: Olorinab
Olorinab high dose (Main Study)ExperimentalNot described
Receives: Drug: Olorinab
Placebo (Main Study)Placebo comparatorNot described
Receives: Drug: Placebo
Olorinab (Long-Term Extension)ExperimentalParticipants will receive olorinab based on their treatment assignment in the Main Study.
Receives: Drug: Olorinab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at 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.

    Measured: Baseline and Week 12

  2. Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Up to 14 Weeks

  3. LTE Period: Number of Participants With TEAEs and SAEs

    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.

    Measured: Up to 54 Weeks

  4. Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    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.

    Measured: Baseline to Week 14

  5. LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    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.

    Measured: Baseline to Week 54 (of LTE)

  6. Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs

    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.

    Measured: Baseline to Week 14

  7. LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs

    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.

    Measured: Baseline to Week 54 (of LTE)

Secondary outcomes (7)

  1. Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at 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.

    Measured: Baseline and Week 12

  2. Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks

    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.

    Measured: Baseline and Week 12

  3. Main Study: Percent Change From Baseline in AAPS at 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.

    Measured: Baseline and Week 12

  4. Main Study: Change From Baseline in Number of Pain-Free Days at 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.

    Measured: Baseline and Week 12

  5. Main Study: Maximum Concentration (Cmax) of Olorinab

    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.

    Measured: 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

  6. Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab

    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.

    Measured: 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

  7. Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab

    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.

    Measured: Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start24 Jul 2019
  3. Primary completion29 Apr 2021
  4. Study completion29 Apr 2021

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043455
Sponsor's protocol ID
APD371-202
Acronym
CAPTIVATE
Status last verified
Sep 2022
First submitted
1 Aug 2019
Last updated
30 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36740814

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olorinab in people with Irritable Bowel Syndrome, run by Arena Pharmaceuticals at 69 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12 (time frame: Baseline and Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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