A phase i study evaluating tolerability, pharmacokinetics, and preliminary efficacy of l-menthol in upper gastrointestinal endoscopy

Clinical Pharmacology and Therapeutics

Volumn 90, Issue 2, 2011, Pages 221-228

  Hiki, N ^a   Kaminishi, M ^b   Hasunuma, T ^c   Nakamura, M ^c   Nomura, S ^d   Yahagi, N ^e   Tajiri, H ^f   Suzuki, H ^f  

^a CANCER INSTITUTE HOSPITAL   (Japan)

^b Showa General Hospital   (Japan)

^c KITASATO UNIVERSITY   (Japan)

^d UNIVERSITY OF TOKYO   (Japan)

^e KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; GLUCURONIC ACID; MENTHOL; MENTHOL GLUCURONIDE; NPO 11; PEPPERMINT OIL; PLACEBO; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ADULT; AIRWAY OBSTRUCTION; AMYLASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXCRETION; DRUG METABOLISM; DRUG TOLERABILITY; DRUG URINE LEVEL; GASTROINTESTINAL ENDOSCOPY; HEADACHE; HEART VENTRICLE EXTRASYSTOLE; HUMAN; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARYNX DISEASE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER ABDOMINAL PAIN;

ADULT; ENDOSCOPY, GASTROINTESTINAL; GASTRIC MUCOSA; GLUCURONATES; GLUCURONIC ACIDS; HUMANS; HYDROXYLATION; MALE; MENTHOL; MIDDLE AGED;

EID: 79960611229     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.110     Document Type: Article

References (25)

1. Kaltenbach, T., Sano, Y., Friedland, S. & Soetikno, R.; American Gastroenterological Association. American Gastroenterological Association (AGA ) Institute technology assessment on image-enhanced endoscopy. Gastroenterology 134, 327-340 (2008).
2. Kwon, R.S. et al.; ASGE Technology Committee. Endocytoscopy. Gastrointest. Endosc. 70, 610-613 (2009).
3. Saito, N., Seshimo, A. & Kameoka, S. Underlying-disease risk for antispasmodic premedication in older patients undergoing investigations of the gastrointestinal tract. Clin. Med. Insights Gastroenterol. 1, 27-31 (2008).
4. Umegaki, E. et al. Risk management for gastrointestinal endoscopy in elderly patients: questionnaire for patients undergoing gastrointestinal endoscopy. J. Clin. Biochem. Nutr. 46, 73-80 (2010).
5. Gonzalez-Mendiola, R., Sanchez Fernandez, C., Prieto Montano, P., Cuevas, M., Cena Delgado, M. & Sanchez Cano, M. Acute urticaria induced by hyoscine butylbromide. Allergy. 59, 787-788 (2004). (Pubitemid 38850357)
6. Hashimoto, T. et al. Safety and efficacy of glucagon as a premedication for upper gastrointestinal endoscopy-a comparative study with butyl scopolamine bromide. Aliment. Pharmacol. Ther. 16, 111-118 (2002). (Pubitemid 34123871)
7. Ikegaya, H., Saka, K., Sakurada, K., Nakamura, M. & Yoshida, K. A case of sudden death after intramuscular injection of butylscopolamine bromide. Leg. Med. (Tokyo). 8, 194-197 (2006). (Pubitemid 43766016)
8. Katoh, K. et al. Comparison of gastric peristalsis inhibition by scopolamine butylbromide and glucagon: evaluation by electrogastrography and analysis of heart rate variability. J. Gastroenterol. 38, 629-635 (2003). (Pubitemid 36974975)
9. Treweeke, P. & Barrett, N.K. Allergic reaction to Buscopan. Br. J. Radiol. 60, 417-418 (1987).
10. Gelfand, D.W., Sowers, J.C., DePonte, K.A., Sumner, T.E. & Ott, D.J. Anaphylactic and allergic reactions during double-contrast studies: is glucagon or barium suspension the allergen? AJR. Am. J. Roentgenol. 144, 405-406 (1985). (Pubitemid 15168353)
11. Herskovitz, P.I. & Sendovski, U. Severe allergic reaction to intravenous injection of glucagon. Radiology 202, 879 (1997).
12. Neoh, C.Y., Tan, A.W. & Leow, Y.H. Delayed hypersensitivity reaction after intravenous glucagon administered for a barium enema: a case report. Ann. Acad. Med. Singap. 35, 279-281 (2006). (Pubitemid 43954364)
13. Eccles, R. Menthol and related cooling compounds. J. Pharm. Pharmacol. 46, 618-630 (1994). (Pubitemid 24249348)
14. Hiki, N. et al. Peppermint oil reduces gastric spasm during upper endoscopy: a randomized, double-blind, double-dummy controlled trial. Gastrointest. Endosc. 57, 475-482 (2003). (Pubitemid 36402712)
15. Martin, D., Valdez, J., Boren, J. & Mayersohn, M. Dermal absorption of camphor, menthol, and methyl salicylate in humans. J. Clin. Pharmacol. 44, 1151-1157 (2004). (Pubitemid 39202459)
16. Mascher, H., Kikuta, C. & Schiel, H. Pharmacokinetics of menthol and carvone after administration of an enteric coated formulation containing peppermint oil and caraway oil. Arzneimittelforschung. 51, 465-469 (2001). (Pubitemid 32588926)
17. Gelal, A., Jacob, P. 3rd, Yu, L. & Benowitz, N.L. Disposition kinetics and effects of menthol. Clin. Pharmacol. Ther. 66, 128-135 (1999). (Pubitemid 29398848)
18. Grigoleit, H.G. & Grigoleit, P. Gastrointestinal clinical pharmacology of peppermint oil. Phytomedicine 12, 607-611 (2005). (Pubitemid 40943538)
19. Dresser, G.K., Wacher, V., Wong, S., Wong, H.T. & Bailey, D.G. Evaluation of peppermint oil and ascorbyl palmitate as inhibitors of cytochrome P4503A4 activity in vitro and in vivo. Clin. Pharmacol. Ther. 72, 247-255 (2002).
20. Wacher, V.J., Wong, S. & Wong, H.T. Peppermint oil enhances cyclosporine oral bioavailability in rats: comparison with D-alpha-tocopheryl poly(ethylene glycol 1000) succinate (TPGS) and ketoconazole. J. Pharm. Sci. 91, 77-90 (2002). (Pubitemid 34074468)
21. Madyastha, K.M. & Srivatsan, V. Studies on the metabolism of l-menthol in rats. Drug Metab. Dispos. 16, 765-772 (1988).
22. Yamaguchi, T., Caldwell, J. & Farmer, P.B. Metabolic fate of [3H]-l-menthol in the rat. Drug Metab. Dispos. 22, 616-624 (1994).
23. Hawthorn, M., Ferrante, J., Luchowski, E., Rutledge, A., Wei, X.Y. & Triggle, D.J. The actions of peppermint oil and menthol on calcium channel dependent processes in intestinal, neuronal and cardiac preparations. Aliment. Pharmacol. Ther. 2, 101-118 (1988).
24. Hills, J.M. & Aaronson, P.I. The mechanism of action of peppermint oil on gastrointestinal smooth muscle. An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology 101, 55-65 (1991).
25. Tozuka, Z. et al. New SRM data dependent exclusion (MS)n measurement for structural determination of drug metabolites using LC/ESI/Ion trap MS. Drug Metab. Pharmacokinet. 18, 390-403 (2003).