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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arena Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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