Trial record 1 of 1 for:
APD371-202 | United States
Olorinab in IBS-C and IBS-D (CAPTIVATE)
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04043455 |
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Recruitment Status :
Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : February 21, 2021
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Sponsor:
Arena Pharmaceuticals
Information provided by (Responsible Party):
Arena Pharmaceuticals
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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 |
| 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 |
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Experimental: Olorinab (Long-Term Extension)
Participants will receive olorinab based on their treatment assignment in the Main Study.
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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 :
- Change in Average Abdominal Pain Score (AAPS) - Main Study [ Time Frame: Baseline to Week 12 ]
- 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 :
- Proportion of Participants Achieving a ≥ 30% Improvement in AAPS - Main Study [ Time Frame: Baseline to Week 12 ]
- 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 ]
- Percent Change in AAPS - Main Study [ Time Frame: Baseline to Week 12 ]
- Mean Change in Number of Pain-free Days per Week - Main Study [ Time Frame: Baseline to Week 12 ]
- Observed Maximum Concentration (Cmax) of Olorinab and its Metabolites - Main Study [ Time Frame: Day 1, Weeks 2 through 14 ]
- 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 ]
- Observed trough (pre-dose) concentration (Ctrough) of Olorinab and its Metabolites - Main Study [ Time Frame: Day 1, Weeks 2 through 14 ]
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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)
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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])
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
Show 69 study locations
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
| Study Director: | Arena CT.gov Administrator | Arena Pharmaceuticals |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Arena Pharmaceuticals:
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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 |