Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
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|ClinicalTrials.gov Identifier: NCT02291445|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : September 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Visceral Pain||Drug: Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule) Drug: Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)||Phase 2|
Rationale: Peppermint oil has shown to be effective in the treatment of 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 plan to conduct a multicenter randomized controlled trial to investigate the possible beneficial effects of peppermint oil in IBS. To improve efficacy and to reduce side effects, the investigators aim to study the use of a new peppermint oil formulation (Tempocol-ColoPulse®) that will slowly release the oil in the (ileo-) colonic region specifically. In order to demonstrate differences in pharmacokinetics, the subsidizing party, ZonMW, requested an additional pilot study (described in the present protocol) in which the investigators will investigate surrogate markers for local colon bioavailability, tolerability and side effects of the new Tempocol-ColoPulse®.
Study design: a randomized, double blind, two-period, two-treatment crossover study with a wash out period of at least 14 days.
Intervention: All study volunteers will receive a single dose of 182mg of both Tempocol-ColoPulse® and Tempocol®, each on a different test day.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects may be confronted with certain inconveniences and minor risks. They are required to visit the MUMC+ 5 times, once for the screening and two times per test day for various non-invasive measurements (questionnaires, blood pressure and heart-rate measurement, urine and fecal sampling, pregnancy test in women in fertile ages, general physical exam) as well as for minor invasive venous blood sampling, after which a small haematoma can occur. Total time investment is +/- 30 hours, subjects will not benefit from participation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||September 2015|
Tempocol-ColoPulse® is a colon-targeted-delivery peppermint oil capsule that will deliver peppermint oil in the (ileo-) colonic region specifically.
Drug: Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
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.
Other Name: Tempocol-ColoPulse®
Active Comparator: Tempocol®
Tempocol® is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Drug: Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule)
Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
Other Name: Tempocol® (CBG-rvg number 109856)
- Difference in T-max [ Time Frame: 24 hours ]Difference in time to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma
- Difference in C-max [ Time Frame: 24 hours ]Difference in menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) peak plasma concentrations
- Difference in T-lag [ Time Frame: 24 hours ]Difference in time until a measurable plasma concentration of menthol-glucuronide occurs after oral administration of peppermint oil
- Difference in AUC [ Time Frame: 24 hours ]Difference in area under the plasma concentration-time curve from t=0 hrs until t=24 hrs.
- T1/2 [ Time Frame: 24 hours ]elimination half-life; time required for the plasma concentration of menthol-glucuronide to reach half of its original value.
- Menthol-glucuronide urine exretion time curve [ Time Frame: 24 hours ]
- L-Menthol concentration in feces [ Time Frame: +/- 24 hours ]
- Difference in total number of side effects per time point. [ Time Frame: 24 hours ]
- Tolerability assessed by heart rate, blood pressure and reported side effects [ Time Frame: 24 hours ]Assessed by heart rate, blood pressure and reported side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291445
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 5800|
|Principal Investigator:||A Masclee, Prof, PhD, MD||Maastricht University Medical Center|