Irritable Bowel Syndrome Clinical Trial
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
Verified date | July 2015 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Khanna R, MacDonald JK, Levesque BG. Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis. J Clin Gastroenterol. 2014 Jul;48(6):505-12. doi: 10.1097/MCG.0b013e3182a88357. Review. — View Citation
Maurer JM, Schellekens RC, van Rieke HM, Stellaard F, Wutzke KD, Buurman DJ, Dijkstra G, Woerdenbag HJ, Frijlink HW, Kosterink JG. ColoPulse tablets perform comparably in healthy volunteers and Crohn's patients and show no influence of food and time of food intake on bioavailability. J Control Release. 2013 Dec 28;172(3):618-24. doi: 10.1016/j.jconrel.2013.09.021. Epub 2013 Oct 2. — View Citation
Ruepert L, Quartero AO, de Wit NJ, van der Heijden GJ, Rubin G, Muris JW. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD003460. doi: 10.1002/14651858.CD003460.pub3. Review. — View Citation
Schellekens RC, Stellaard F, Olsder GG, Woerdenbag HJ, Frijlink HW, Kosterink JG. Oral ileocolonic drug delivery by the colopulse-system: a bioavailability study in healthy volunteers. J Control Release. 2010 Sep 15;146(3):334-40. doi: 10.1016/j.jconrel.2010.05.028. Epub 2010 May 31. — View Citation
Weerts ZZRM, Keszthelyi D, Vork L, Aendekerk NCP, Frijlink HW, Brouwers JRBJ, Neef C, Jonkers DMAE, Masclee AAM. A Novel Ileocolonic Release Peppermint Oil Capsule for Treatment of Irritable Bowel Syndrome: A Phase I Study in Healthy Volunteers. Adv Ther. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | T-max | Time to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma | 24 hours | |
Secondary | C-max | Menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) peak plasma concentrations | 24 hours | |
Secondary | T-lag | Time until a measurable plasma concentration of menthol-glucuronide occurs after oral administration of peppermint oil (45ug/L) | 24 hours | |
Secondary | AUC | Area under the plasma concentration-time curve from t=0 hrs until t=24 hrs. | 24 hours | |
Secondary | T1/2 | elimination half-life; time required for the plasma concentration of menthol-glucuronide to reach half of its original value. | 24 hours | |
Secondary | Menthol-glucuronide Urine Exretion Time Curve | 24 hours | ||
Secondary | L-Menthol Concentration in Feces | +/- 24 hours | ||
Secondary | Difference in Total Number of Side Effects Per Time Point. | 24 hours | ||
Secondary | Tolerability Assessed by Heart Rate, Blood Pressure and Reported Side Effects | Assessed by heart rate, blood pressure and reported side effects. | 24 hours |
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