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Trial record 1 of 1 for:    APD371-202 | United States
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Olorinab in IBS-C and IBS-D (CAPTIVATE)

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ClinicalTrials.gov Identifier: NCT04043455
Recruitment Status : Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Olorinab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 24, 2019
Actual Primary Completion Date : January 6, 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Experimental: Olorinab low dose (Main Study) Drug: Olorinab
Olorinab Dose 1 capsule or tablet by mouth, 3 times a day up to 12 weeks
Other Name: APD371

Experimental: Olorinab medium dose (Main Study) Drug: Olorinab
Olorinab Dose 2 capsule or tablet by mouth, 3 times a day up to 12 weeks
Other Name: APD371

Experimental: Olorinab high dose (Main Study) Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times a day up to 12 weeks
Other Name: APD371

Placebo Comparator: Placebo (Main Study) Drug: Placebo
Olorinab matching placebo capsule or tablet by mouth, 3 times a 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 2 capsule or tablet by mouth, 3 times a day up to 52 weeks
Other Name: APD371

Drug: Olorinab
Olorinab Dose 3 capsule or tablet by mouth, 3 times a day up to 52 weeks
Other Name: APD371




Primary Outcome Measures :
  1. Change in Average Abdominal Pain Score (AAPS) - Main Study [ Time Frame: Baseline to Week 12 ]
  2. Number and Severity of Safety Measures - Main Study and Long-Term Extension Period [ Time Frame: Up to approximately 14 weeks (Main Study) and 54 weeks (Long-Term Extension Period) ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.


Secondary Outcome Measures :
  1. Proportion of Participants Achieving a ≥ 30% Improvement in AAPS - Main Study [ Time Frame: Baseline to Week 12 ]
  2. Proportion of Participants Achieving a ≥ 30% Improvement in AAPS for at least 6 of the 12 Weeks During the Main Study Treatment Period [ Time Frame: Baseline to Week 12 ]
  3. Percent Change in AAPS - Main Study [ Time Frame: Baseline to Week 12 ]
  4. Mean Change in Number of Pain-free Days per Week - Main Study [ Time Frame: Baseline to Week 12 ]
  5. Observed Maximum Concentration (Cmax) of Olorinab and its Metabolites - Main Study [ Time Frame: Day 1, Weeks 2 through 14 ]
  6. Time of Observed Maximum (peak) Concentration after drug administration (Tmax) of Olorinab and its Metabolites - Main Study [ Time Frame: Day 1, Weeks 2 through 14 ]
  7. Observed trough (pre-dose) concentration (Ctrough) of Olorinab and its Metabolites - Main Study [ Time Frame: Day 1, Weeks 2 through 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043455


Locations
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Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04043455    
Other Study ID Numbers: APD371-202
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
Abdominal pain
Olorinab
APD371
Irritable bowel syndrome (IBS)
IBS-C (IBS with predominant constipation)
IBS-D (IBS with predominant diarrhea)
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases