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

NCT04043455 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2025-01-30

Study results available
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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

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

Sponsors & Collaborators

  • Arena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Arena CT.gov Administrator · Arena Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2021-04-29
Completion
2021-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04043455 on ClinicalTrials.gov