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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
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a colon-targeted-delivery capsule (Tempocol-ColoPulse®) and an enteric-coated capsule (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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tempocol-ColoPulse®
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)




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Difference in AUC [ Time Frame: 24 hours ]
    Difference in area under the plasma concentration-time curve from t=0 hrs until t=24 hrs.

  3. 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.

  4. Menthol-glucuronide urine exretion time curve [ Time Frame: 24 hours ]
  5. L-Menthol concentration in feces [ Time Frame: +/- 24 hours ]
  6. Difference in total number of side effects per time point. [ Time Frame: 24 hours ]
  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (<55 years old) must use contraception or be postmenopausal for at least two years

Exclusion Criteria:

  • History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol
  • Use of medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator)
  • Dieting (for example lactose-free, gluten-free, caloric-restrictive, vegetarian or vegan, macrobiotic diet)
  • Pregnancy, lactation
  • High alcohol consumption (>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)

Information from the National Library of Medicine

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


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 5800
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: A Masclee, Prof, PhD, MD Maastricht University Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02291445    
Other Study ID Numbers: 50941
2014-004195-32 ( EudraCT Number )
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: July 2015
Keywords provided by Maastricht University Medical Center:
Peppermint oil
Menthol
Volatile oil
Plant oil
Visceral pain
Abdominal pain
Irritable bowel syndrome (IBS)
Colonic disease
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases
Abdominal Pain
Visceral Pain
Colonic Diseases, Functional
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Nociceptive Pain
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics