CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
Ileocolonic release peppermint oil +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02716285
NCT02716285Phase 3Completed
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Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery

Maastricht University Medical Center·interventional·Posted Mar 23, 2016·Updated Nov 2, 2018

In Brief

A Phase 3 clinical trial evaluating Ileocolonic release peppermint oil, Placebo, and 1 other intervention for Irritable Bowel Syndrome and 2 related conditions. Completed, enrolled 190 participants across 4 sites.

Detailed Summary

Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint oil remains relatively under-used in IBS. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in IBS patients according to current European Medicines Agency (EMA) / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce side effects, the investigators aim to study the use of a new peppermint oil formulation, a colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region specifically.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome, Abdominal Pain, Colonic Diseases, Functional
CountriesNetherlands
CollaboratorsZonMw: The Netherlands Organisation for Health Research and Development

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 23, 2016
Enrollment StartAug 17, 2016
Primary CompletionMay 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.3 years ago

Interventions

Ileocolonic release peppermint oildrug

Peppermint oil, menthae piperitae aetheroleum

Placebodrug

Placebo capsule, containing microcrystalline cellulose

Small intestinal release peppermint oildrug

Peppermint oil, menthae piperitae aetheroleum