Trial Outcomes & Findings for Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study (NCT NCT02291445)
NCT ID: NCT02291445
Last Updated: 2022-01-24
Results Overview
Time to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 hours
Results posted on
2022-01-24
Participant Flow
This was a crossover design.
Participant milestones
| Measure |
Ileocolonic Release PO First, Then Small-intestinal Release Peppermint Oil
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO First, Then Ileocolonic Release Peppermint Oil
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Baseline characteristics by cohort
| Measure |
Ileocolonic Release PO on First Test Day
n=4 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO on First Test Day
n=4 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.7 years
n=5 Participants
|
24.1 years
n=7 Participants
|
22.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
BMI
|
21.5 kg/m^2
n=5 Participants
|
21.7 kg/m^2
n=7 Participants
|
21.5 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursTime to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma
Outcome measures
| Measure |
Ileocolonic Release PO
n=8 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
T-max
|
360 minutes
Interval 360.0 to 405.0
|
180 minutes
Interval 120.0 to 180.0
|
SECONDARY outcome
Timeframe: 24 hoursMenthol-glucuronide (main constituent of peppermint oil after conversion by the liver) peak plasma concentrations
Outcome measures
| Measure |
Ileocolonic Release PO
n=8 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
C-max
|
563.6 ug/L
Interval 268.0 to 849.0
|
702 ug/L
Interval 644.0 to 1020.0
|
SECONDARY outcome
Timeframe: 24 hoursTime until a measurable plasma concentration of menthol-glucuronide occurs after oral administration of peppermint oil (45ug/L)
Outcome measures
| Measure |
Ileocolonic Release PO
n=8 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
T-lag
|
225 minutes
Interval 204.0 to 284.0
|
37 minutes
Interval 6.0 to 65.0
|
SECONDARY outcome
Timeframe: 24 hoursArea under the plasma concentration-time curve from t=0 hrs until t=24 hrs.
Outcome measures
| Measure |
Ileocolonic Release PO
n=8 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
AUC
|
2331 ug*h/L
Interval 2006.0 to 2510.0
|
2623 ug*h/L
Interval 2471.0 to 2920.0
|
SECONDARY outcome
Timeframe: 24 hourselimination half-life; time required for the plasma concentration of menthol-glucuronide to reach half of its original value.
Outcome measures
| Measure |
Ileocolonic Release PO
n=8 Participants
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 Participants
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
T1/2
|
6.1 hours
Interval 5.1 to 7.4
|
7.7 hours
Interval 7.0 to 10.8
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: No urine analysis was performed due to lack in funding. In addition, it was felt that the systemic concentration of menthol glucuronide concentration provided enough information to answer the research question.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: +/- 24 hoursOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursAssessed by heart rate, blood pressure and reported side effects.
Outcome measures
Outcome data not reported
Adverse Events
Ileocolonic Release PO
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Small Intestinal Release PO
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ileocolonic Release PO
n=8 participants at risk
Ileocolonic release PO is a targeted ileocolonic release peppermint oil capsule that releases peppermint oil in the (ileo-) colonic region specifically.
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.
|
Small Intestinal Release PO
n=8 participants at risk
Small Intestinal Release PO (Tempocol®) is an enteric-coated peppermint oil capsule that delivers peppermint oil in the upper small intestine.
Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
|
|---|---|---|
|
Gastrointestinal disorders
Acid regurgitation
|
0.00%
0/8
|
25.0%
2/8
|
|
Gastrointestinal disorders
Fecal urgency
|
0.00%
0/8
|
25.0%
2/8
|
|
General disorders
Headache
|
25.0%
2/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Altered Fecal Odor
|
25.0%
2/8
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place