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Trial record 5 of 5 for:    Recruiting Studies | Interventional Studies | IBS - Irritable Bowel Syndrome | United States | Adult | Phase 2 | Industry

Olorinab in IBS-C and IBS-D (CAPTIVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043455
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : April 9, 2020
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
Estimated Enrollment : 240 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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

Placebo Comparator: Placebo Drug: Placebo
Olorinab matching placebo capsule or tablet by mouth, 3 times a day up to 12 weeks




Primary Outcome Measures :
  1. Change in Average Abdominal Pain Scale (AAPS) [ Time Frame: Baseline to Week 12 ]
  2. Number and Severity of Safety Measures [ Time Frame: Up to approximately 14 weeks ]
    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 [ 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 Treatment Period [ Time Frame: Baseline to Week 12 ]
  3. Percent Change in AAPS [ Time Frame: Baseline to Week 12 ]
  4. Mean Change in Number of Pain-free Days per Week [ Time Frame: Baseline to Week 12 ]
  5. Observed Maximum Concentration (Cmax) of Olorinab and its Metabolites [ Time Frame: Day 1, Weeks 2 through 14 ]
  6. Time of Observed Maximum (peak) Concentration after drug administration (Tmax) of Olorinab and its Metabolites [ Time Frame: Day 1, Weeks 2 through 14 ]
  7. Observed trough (pre-dose) concentration (Ctrough) of Olorinab and its Metabolites [ 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

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])

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], cholecystectomy, stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). 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)

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


Contacts
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Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com

Locations
Show Show 69 study locations
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: April 9, 2020
Last Verified: April 2020
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