CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule) +1 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/NCT02291445
NCT02291445Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Single Dose, Two Treatment, Two Period Crossover Pharmacokinetic Study Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®) in Healthy Volunteers

Maastricht University Medical Center·interventional·Posted Nov 14, 2014·Updated Jan 24, 2022

In Brief

A Phase 2 clinical trial evaluating Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule) and Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule) for Irritable Bowel Syndrome and 3 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®). This study is conducted as part of a future multicenter randomized controlled trial that will assess the therapeutic effect of the new peppermint oil formulation in IBS patients.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartMar 1, 2015
Primary CompletionJul 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.6 years ago

Interventions

Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule)drug

Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.

Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)drug

Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region.