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

• ClinicalTrials.gov Identifier: NCT04043455
• Recruitment Status: Recruiting
• First Posted: August 2, 2019
• Last Update Posted: August 2, 2019
• Sponsor: Arena Pharmaceuticals
• Information provided by (Responsible Party): Arena Pharmaceuticals

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Olorinab low dose	Drug: Olorinab; Olorinab Dose 1 capsule by mouth, 3 times a day up to 12 weeks; Other Name: APD371
Experimental: Olorinab medium dose	Drug: Olorinab; Olorinab Dose 2 capsule by mouth, 3 times a day up to 12 weeks; Other Name: APD371
Experimental: Olorinab high dose	Drug: Olorinab; Olorinab Dose 3 capsule by mouth, 3 times a day up to 12 weeks; Other Name: APD371
Placebo Comparator: Placebo	Drug: Placebo; Olorinab matching placebo capsule by mouth, 3 times a day up to 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Change in the Weekly 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 Concentration (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 ]

Eligibility Criteria

• 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)

• Participants over 50 years of age are required to have 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)

Contacts and Locations

Contacts

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

Locations

United States, Alabama

Clinical Research Associates, LLC; Recruiting

Huntsville, Alabama, United States, 35801

United States, Florida

Clinical Research of Brandon, LLC; Recruiting

Brandon, Florida, United States, 33511

United States, Georgia

Clinical Research Atlanta; Recruiting

Stockbridge, Georgia, United States, 30281

United States, Ohio

Great Lakes Gastroenterology Research, LLC; Recruiting

Mentor, Ohio, United States, 44060

United States, Virginia

New River Valley Research Institute; Recruiting

Christiansburg, Virginia, United States, 24073

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

• Study Director: Arena CT.gov Administrator; Arena Pharmaceuticals

More Information

• Responsible Party: Arena Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04043455
• Other Study ID Numbers: APD371-202
• First Posted: August 2, 2019
• Last Update Posted: August 2, 2019
• Last Verified: August 2019

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:

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

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases