TerminatedPhase 2

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

Stopped: Business Decision

United States273 participantsStarted 2019-07-24

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 \[Screening\])

What they're measuring

Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12

Timeframe: Baseline and Week 12

Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 14 Weeks

LTE Period: Number of Participants With TEAEs and SAEs

Timeframe: Up to 54 Weeks

Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

Timeframe: Baseline to Week 14

LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

Timeframe: Baseline to Week 54 (of LTE)

Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs

Timeframe: Baseline to Week 14

LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs

Timeframe: Baseline to Week 54 (of LTE)

Trial details

NCT IDNCT04043455

SponsorArena Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-29

Results submitted2022-08-05

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials