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

NCT02291445 | Completed Phase 2 Results

• 2 other identifiers: 509412014-004195-32
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Peppermint oil; Menthol; Volatile oil; Plant oil; Visceral pain; Abdominal pain; Irritable bowel syndrome (IBS); Colonic disease

Outcome Measures

Primary Outcomes (1)

• T-max

  Time to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma

  24 hours

Secondary Outcomes (8)

• C-max

  24 hours

• T-lag

  24 hours

• AUC

  24 hours

• T1/2

  24 hours

• Menthol-glucuronide Urine Exretion Time Curve

  24 hours

Study Arms (2)

Tempocol-ColoPulse®

EXPERIMENTAL

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)

Tempocol®

ACTIVE COMPARATOR

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)

Interventions

Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule) DRUG

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

Also known as: Tempocol® (CBG-rvg number 109856)

Tempocol®

Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule) DRUG

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.

Also known as: Tempocol-ColoPulse®

Tempocol-ColoPulse®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 5800, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 24096020 BACKGROUND

• 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.

  PMID: 20621586 BACKGROUND

• 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.

  PMID: 24100754 BACKGROUND

• 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;2011(8):CD003460. doi: 10.1002/14651858.CD003460.pub3.

  PMID: 21833945 BACKGROUND

• 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. 2018 Nov;35(11):1965-1978. doi: 10.1007/s12325-018-0802-1. Epub 2018 Oct 4.

  PMID: 30284674 RESULT

MeSH Terms

Conditions

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

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Nociceptive Pain

Results Point of Contact

• Title: Z. Weerts
• Organization: Maastricht University (Medical Center)

z.weerts@maastrichtuniversity.nl

Study Officials

• A Masclee, Prof, PhD, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2015-07

Locations

NL (1)