NCT04043455

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Arena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Olorinab	Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
DRUG	Olorinab	Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
DRUG	Olorinab	Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
DRUG	Placebo	Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
DRUG	Olorinab	Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
DRUG	Olorinab	Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks

Timeline

• Start date: 2019-07-24
• Primary completion: 2021-04-29
• Completion: 2021-04-29
• First posted: 2019-08-02
• Last updated: 2025-01-30
• Results posted: 2022-10-12

Locations

69 sites across 1 country: United States

Regulatory

• FDA-regulated drug study