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

NCT04043455 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: APD371-202
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 69

Brief 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).

Conditions

Irritable Bowel Syndrome

Keywords

Abdominal pain; Olorinab; APD371; Irritable bowel syndrome (IBS); IBS-C (IBS with predominant constipation); IBS-D (IBS with predominant diarrhea)

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline and Week 12

• 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.

  Up to 14 Weeks

• 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.

  Up to 54 Weeks

• 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.

  Baseline to Week 14

• 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.

  Baseline to Week 54 (of LTE)

• 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.

  Baseline to Week 14

• 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.

  Baseline to Week 54 (of LTE)

Secondary Outcomes (7)

• Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12

  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

  Baseline and Week 12

• Main Study: Percent Change From Baseline in AAPS at Week 12

  Baseline and Week 12

• Main Study: Change From Baseline in Number of Pain-Free Days at Week 12

  Baseline and Week 12

• Main Study: Maximum Concentration (Cmax) of Olorinab

  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

Study Arms (5)

Olorinab low dose (Main Study)

EXPERIMENTAL

Drug: Olorinab

Olorinab medium dose (Main Study)

EXPERIMENTAL

Drug: Olorinab

Olorinab high dose (Main Study)

EXPERIMENTAL

Drug: Olorinab

Placebo (Main Study)

PLACEBO COMPARATOR

Drug: Placebo

Olorinab (Long-Term Extension)

EXPERIMENTAL

Participants will receive olorinab based on their treatment assignment in the Main Study.

Drug: Olorinab

Interventions

Olorinab DRUG

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

Also known as: APD371

Olorinab low dose (Main Study)

Placebo DRUG

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

Placebo (Main Study)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Colonoscopy (within 10 years of Visit 1 \[Screening\])
• Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 \[Screening\])
• Computed tomography colonography (within 5 years of Visit 1 \[Screening\])

You may not qualify if:

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

Sponsors & Collaborators

• Arena Pharmaceuticals: lead

Study Sites (69)

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

Clinical Research Associates, LLC

Huntsville, Alabama, 35801, United States

Location

East Valley Gastroenterology and Hepatology Associates

Chandler, Arizona, 85224, United States

Location

Gilbert Center for Family Medicine

Gilbert, Arizona, 85298, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

GW Research, Inc.

Chula Vista, California, 91910, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Diagnamics Inc.

Encinitas, California, 92024, United States

Location

Prime Care Clinical Research

Laguna Hills, California, 92653, United States

Location

Om Research, Attn: Heather Blunt

Lancaster, California, 93534, United States

Location

San Diego Gastroenterology Medical Associates (CTNx)

San Diego, California, 92103, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

Advanced Rx Clinical Research Group, Inc.

Westminster, California, 92683, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Clinical Research of Brandon, LLC

Brandon, Florida, 33511, United States

Location

Qps Mra, Llc

South Miami, Florida, 33143, United States

Location

Precision Clinical Research, LLC.

Sunrise, Florida, 33351, United States

Location

Presicion Research Center Inc

Tampa, Florida, 33603, United States

Location

Agile Clinical Research Trials LLC

Atlanta, Georgia, 30328, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Gastroenterology Associates of Gainesville Georgia

Gainesville, Georgia, 30501, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Advanced Clinical Research, Attn to: Owen Havey

Meridian, Idaho, 83642, United States

Location

Claude Mandel Medical Center

Chicago, Illinois, 60617, United States

Location

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, 60181, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

WestGlenGI

Shawnee Mission, Kansas, 66217, United States

Location

CroNOLA, LLC

Houma, Louisiana, 70360, United States

Location

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Frederick Gastroenterology Associates

Frederick, Maryland, 21701, United States

Location

Flint Clinical Research, PLLC

Flint, Michigan, 48503, United States

Location

Center for Pharmaceutical Research, LLC an AMR company

Kansas City, Missouri, 64114, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

Location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

Great Lakes Medical Research

Beachwood, Ohio, 44122, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

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

Wadsworth, Ohio, 44281, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Lynn Institute of Tulsa

Tulsa, Oklahoma, 74105, United States

Location

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

Salem, Oregon, 97301, United States

Location

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

Location

Care Access Research, Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Meridian Clinical Research, LLC

Dakota Dunes, South Dakota, 57049, United States

Location

Chattanooga Research & Medicine, PLLC

Chattanooga, Tennessee, 37404, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Research Studies at Fine Digestive Health

Irving, Texas, 75039, United States

Location

ACR Gut Whisperer

West Jordan, Utah, 84088, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

Exemplar Research Inc

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

• 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.

  PMID: 36740814 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

olorinab

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Arena CT.gov Administrator
• Organization: Arena Pharmaceuticals, Inc.

ct.gov@arenapharm.com

+1 855-218-9153

Study Officials

• Arena CT.gov Administrator

  Arena Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: July 24, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: January 30, 2025
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (69)