Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D) (CAPTIVATE)

Arena Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Olorinab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04043455

APD371-202

Details and patient eligibility

About

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).

Enrollment: 273 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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273 participants in 5 patient groups, including a placebo group

Olorinab low dose (Main Study)

Experimental group

Treatment:

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Olorinab medium dose (Main Study)

Experimental group

Treatment:

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Olorinab high dose (Main Study)

Experimental group

Treatment:

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Placebo (Main Study)

Placebo Comparator group

Treatment:

Drug: Placebo

Olorinab (Long-Term Extension)

Experimental group

Description:

Participants will receive olorinab based on their treatment assignment in the Main Study.

Treatment:

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab

Drug: Olorinab