NCT02291445View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

July 31, 2015

Study Completion Date

September 30, 2015

Conditions
Irritable Bowel SyndromeAbdominal PainColonic DiseasesVisceral Pain
Interventions
DRUG

Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule)

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

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.

Trial Locations (1)

5800

Maastricht University Medical Center, Maastricht

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Maastricht University Medical Center

OTHER

NCT02291445 - Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study | Biotech Hunter | Biotech Hunter