Extended analysis of a double-blind, placebo-controlled, 15-week study with otilonium bromide in irritable bowel syndrome

European Journal of Gastroenterology and Hepatology

Volumn 14, Issue 12, 2002, Pages 1331-1338

  Glende, Manfred ^d   Morselli Labate, Antonio M ^a   Battaglia, Giuseppe ^b   Evangelista, Stefano ^c  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b SS Giovanni e Paolo Hospital   (Italy)

^c Menarini Ricerche SpA   (Italy)

^d NONE

Author keywords

Diarrhoea; Irritable bowel syndrome; Otilonium bromide; Pain; Spasmolytics

Indexed keywords

OTILONIUM BROMIDE;

ADULT; ARTICLE; CLINICAL TRIAL; COLON DILATATION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; EVALUATION; FECES ANALYSIS; FEMALE; HUMAN; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; METEORISM; PAIN; PRIORITY JOURNAL; SYMPTOM; TREATMENT OUTCOME;

ADULT; COLONIC DISEASES, FUNCTIONAL; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; PAIN; PAIN MEASUREMENT; QUATERNARY AMMONIUM COMPOUNDS; TREATMENT OUTCOME;

EID: 0036932020     PISSN: 0954691X     EISSN: None     Source Type: Journal    
DOI: 10.1097/00042737-200212000-00008     Document Type: Article

References (37)

1. Drossman DA, Whitehead WE, Camilleri M. Irritable bowel syndrome: A technical review for practice guideline development. Gastroenterology 1997; 112:2120-2137.
2. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA, et al. Functional bowel disorders and functional abdominal pain. Gut 1999; 45(Suppl II):II43-II47.
3. Drossman DA. An integrated approach to the irritable bowel syndrome [review article]. Aliment Pharmacol Ther 1999; 13(Suppl 2):3-14.
4. Drossman DA, Thompson WG. The irritable bowel syndrome: Review and a graduated multicomponent treatment approach. Ann Intern Med 1992; 116:1009-1016.
5. 3 receptor antagonist. Aliment Pharmacol Ther 1999; 13:1149-1159.
6. Maggi CA, Manzini S, Meli A. Regional selectivity of calcium blockers at intestinal level. Arch Int Pharmacodyn Ther 1985; 276:202-221.
7. Evangelista S. Otilonium bromide: A selective spasmolytic for the gastrointestinal tract. J Intern Med Res 1999; 27:207-222.
8. 2+ channels and secretion in rat chromaffin cells. Eur J Pharmacol 1996; 298:199-205.
9. Giachetti A. Pharmacological studies on otilonium bromide. Ital J Gastroenterol 1991; 23(Suppl 1):56-59.
10. Maggi CA, Manzini S, Meli A. Octylonium bromide: A smooth muscle relaxant which interferes with calcium ion mobilization. Arch Int Pharmacodyn Ther 1983; 264:305-323.
11. Santicioli P, Zagorodnyuk V, Renzetti AR, Maggi CA. Antimuscarinic, calcium channel blocker and tachykinin NK2 receptor antagonist actions of otilonium bromide in the circular muscle of guinea-pig colon. Naunyn-Schmiedeberg's Arch Pharmacol 1999; 359:420-427.
12. Baldi F, Corinaldesi R, Ferrarini F, Balestra R, Brunetti G, Cassan M, et al. Clinical and functional evaluation of octylonium bromide in the treatment of irritable bowel syndrome. A double-blind controlled trial. Clin Trials J 1983; 20:77-88.
13. Baldi F, Longanesi A, Blasi A, Monello S, Cestari R, Missale G, et al. Octylonium bromide in the treatment of the irritable bowel syndrome: A clinical-function study. Hepato-Gastroenterology 1992; 39:392-395.
14. Barbier P. Etude controlée en double aveugle d'un nouvel antispasmodique colique. Ars Medici 1981; 36:1879-1880.
15. Castiglione F, Daniele B, Mazzacca G. Therapeutic strategy for the irritable bowel syndrome. Ital J Gastroenterol 1991; 23(Suppl 1 ):53-55.
16. Capurso L, Koch M, Tarquini M, Dezi A, Papi C, Fracasso P. The irritable bowel syndrome, a cross-over study of octilonium bromide, mebeverine and placebo. Clin Trials J 1984; 21:285-291.
17. DeFrance P, Casini A. A comparison of the action of octylonium bromide and pinaverium bromide: Study conducted under clinical control. Ital J Gastroenterol 1991; 23(Suppl 1):64-66.
18. Ferrari A, Cavallero M, Spandre M, Gemme C, Rossini FP, Imbimbo BP. Double blind study of a new antimuscarinic, cimetropium bromide, in patients with irritable bowel syndrome. Clin Ther 1986; 8:320-328.
19. Villagrasa M, Boix J, Humbert P, Quer JC. Aleatory clinical study comparing otilonium bromide with a fiber-rich diet in the treatment of irritable bowel syndrome. Ital J Gastroenterol 1991, 23(Suppl 1):67-70.
20. Drossman DA, Thompson WG, Talley NG. Identification of subgroups of functional gastrointestinal disorders. Gastroenterol Int 1990; 3:159-172.
21. Battaglia G, Morselli-Labate AM, Camarri E, Francavilla A, De Marco F, Mastropaolo G, et al. Otilonium bromide in irritable bowel syndrome: A double-blind, placebo-controlled, 15-week study. Aliment Pharmacol Ther 1998; 12:1003-1010.
22. Fass R, Longstreth GF, Pimentel M, Fullerton S, Russak SM, Chiou C-F, et al. Evidence- and consensus-based practice guidelines for the diagnosis of irritable bowel syndrome. Arch Int Med 2001; 161:2081-2088.
23. Mangel AW, Hahn BA, Heath AT, Northcutt AR, Kong S, Dukes GE, et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Intern Med Res 1998; 26:76-81.
24. Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR. Design of treatment trials for functional gastrointestinal disorders. Gut 1999; 45(Suppl II):II69-II77.
25. Whitehead WE. Definition of a responder in clinical trials for functional gastrointestinal disorders: Report on a symposium. Gut 1999; 45(Suppl II):II78-II79.
26. Klein KB. Controlled treatment trials in the irritable bowel syndrome: A critique. Gastroenterology 1988; 95:232-241.
27. Jailwala J, Imperiale TF, Kroenke K. Pharmacologic treatment of the irritable bowel syndrome: A systematic review of randomized, controlled trials. Ann Intern Med 2000; 133:136-147.
28. Poynard T, Regimbeau C, Benhamou Y. Meta-analysis of smooth muscle relaxants in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2001; 15:355-361.
29. Bardhan KD, Bodemar G, Geldof H, Schutz E, Heath A, Mills JG, et al. A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2000; 14:23-24.
30. Camilleri M. Pharmacology and clinical experience with alosetron. Exp Opin Invest Drugs 2000; 9:147-159.
31. Camilleri M. Review article: Tegaserod. Aliment Pharmacol Ther 2001; 15:277-299.
32. Camilleri M, Northcutt AR, Kong S, Dukes GE, McSorley D, Mangel AW. Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial. Lancet 2000; 355:1035-1040.
33. Amenta F, Baroldi P, Ferrante F, Napoleone P, Meli A. Autoradiographic localization of otilonium bromide binding sites in the rat gastrointestinal tract. Arch Int Pharmacodyn Ther 1991; 311:5-19.
34. 14C-otilonium bromide in the rat: Evidence for selective tropism for large intestine after oral administration. Drug Metab Disp 2000; 28:643-647.
35. Signorini C, Tosoni S, Ballerini R, Chinol M, Mannucci C. A study of the absorption of octylonium bromide following oral administration in man. Drugs Exp Clin Res 1984; 10:273-276.
36. Narducci F, Bassotti G, Granata MT, Pelli MA, Gaburri M, Palumbo R, et al. Colonic motility and gastric emptying in patients with irritable colon syndrome. Effect of pretreatment with octylonium bromide. Dig Dis Sci 1986; 31:241-246.
37. Sutton JA, Kilminster SG, Mould GP. The clinical pharmacology of single doses of otilonium bromide in healthy volunteers. Eur J Clin Pharmacol 1997; 52:365-369.