Phase 2 N=8 Randomized Triple-blind Basic Science

Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study

Irritable Bowel Syndrome · Abdominal Pain · Colonic Diseases · Visceral Pain

Bottom Line

View on ClinicalTrials.gov: NCT02291445 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: T-max — 360; 180 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule) (Drug); Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Maastricht University Medical Center
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY T-max	360; 180	—
SECONDARY C-max	563.6; 702	—
SECONDARY T-lag	225; 37	—
SECONDARY AUC	2331; 2623	—
SECONDARY T1/2	6.1; 7.7	—
SECONDARY Menthol-glucuronide Urine Exretion Time Curve	—	—
SECONDARY L-Menthol Concentration in Feces	—	—
SECONDARY Difference in Total Number of Side Effects Per Time Point.	—	—
SECONDARY Tolerability Assessed by Heart Rate, Blood Pressure and Reported Side Effects	—	—

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.

Eligibility Criteria

Inclusion Criteria

Based on medical history and previous examination, no gastrointestinal complaints can be defined
Age between 18 and 65 years
BMI between 18 and 25 kg/m2 and a weight of at least 50 kilograms
Women in fertile age ( 15 alcoholic consumptions per week)
Smoking/ Using drugs of abuse
Self-admitted HIV-positive state
Known allergic reaction to peppermint
High intake of caffeine (>8 cups coffee a day)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02291445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.