Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial

Lancet

Volumn 355, Issue 9209, 2000, Pages 1035-1040

  Camilleri, Michael ^a   Northcutt, Allison R ^b   Kong, Steven ^b   Dukes, George E ^b   McSorley, David ^b   Mangel, Allen W ^b  

^a MAYO CLINIC   (United States)

^b GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; SEROTONIN 3 ANTAGONIST;

ABDOMINAL PAIN; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; INTESTINE FUNCTION; IRRITABLE COLON; MAJOR CLINICAL STUDY; MENTAL DISEASE; NEUROLOGIC DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SKIN DISEASE; URINARY TRACT DISEASE;

EID: 0034712539     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(00)02033-X     Document Type: Article

References (27)

1. Everhart J., Renault P. Irritable bowel syndrome in office- based practice in the United States. Gastroentero logy. 100:1991;998-1003.
2. Jones R., Lydeard S. Irritable bowel syndrome in the general population. BMJ. 304:1992;87-90.
3. Hahn B.A., Yan S., Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion. 60:1999;77-81.
4. Patrick D.L., Drossman D.A., Frederick I.O., DiCesare J., Puder K.L. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 43:1998;400-411.
5. Whitehead W.E., Burnett C.K., Cook E.W. Jr., Taub E. Impact of irritable bowel syndrome on quality of life. Dig Dis Sci. 41:1996;2248-2253.
6. Wells N.E., Hahn B.A., Whorwell P.J. Clinical economics review: irritable bowel syndrome. Aliment Pharmacol Ther. 11:1997;1019-1030.
7. Prior A., Read N.W. Reduction of rectal sensitivity and post-prandial motility by granisetron, a 5 HT-receptor antagonist, in patients with irritable bowel syndrome. Aliment Pharmacol Ther. 7:1993;175-180.
8. Delvaux M., Louvel D., Mamet J.P., Campos-Oriola R., Frexinos J. Effect of alosetron on responses to colonic distension in patients with irritable bowel syndrome. Aliment Pharmacol Ther. 12:1998;849-855.
9. Zighelboim J., Talley N.J., Phillips S.F., Harmsen W.S., Zinsmeister A.R. Visceral perception in irritable bowel syndrome: rectal and gastric responses to distension and serotonin type 3 antagonism. Dig Dis Sci. 40:1995;819-827.
10. Maxton D.G., Morris J., Whorwell P.J. Selective 5-hydroxytryptamine antagonism: a role in irritable bowel syndrome and functional dyspepsia? Aliment Pharmacol Ther. 10:1996;595-599.
11. Goldberg P.A., Kamm M.A., Setti-Carraro P., van der Sijp J.R., Roth C. Modification of visceral sensitivity and pain and irritable bowel syndrome by 5-HT, antagonism (ondansetron). Digestion. 57:1996;478-483.
12. Gore S., Gilmore I.T., Haigh C.G., Brownless S.M., Stockdale H., Morris A.I. Colonic transit in man is slowed by ondansetron (GR38032F), a selective 5-hydroxytryptamine receptor (type 3) antagonist. Aliment Pharmacol Ther. 4:1990;139-144.
13. Bardhan K., Bodemar G., Geldor H.et al. A double-blind placebo-controlled study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 14:2000;23-34.
14. Camilleri M., Mayer E., Drossman D.et al. Improvement in pain and bowel function in female irritable bowel syndrome patients with alosetron, a 5-HT3-receptor antagonist. Aliment Pharmacol Ther. 14:1999;1149-1151.
15. Thompson W., Creed F., Drossman D., Heaton K., Mazzacca G. Functional bowel disorders and functional abdominal pain. Gastrointest J. 5:1992;75-91.
16. Forster J., Houghton L., Whorwell P. Alosetron slows colonic transit in patients with irritable bowel syndrome. Gastroenterology. 112:1997;732.
17. Harding J.P., Hamm L.R., Ehsanullah R.S.et al. Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome. Aliment Pharmacol Ther. 11:1997;1073-1076.
18. Klein K. Controlled treatment trials in the irritable bowel syndrome: a critique. Gastroenterology. 95:1988;232-241.
19. Northcutt A., Harding J., Kong S.et al. Urgency as an endpoint in IBS. Gastroenterology. 116:1999;1036.
20. Mangel A.W., Hahn B.A., Heath A.T.et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res. 26:1998;76-81.
21. Mangel A.W., Northcutt A.R., Kong S., McSorley D. Validation of adequate relief as an endpoint in irritable bowel syndrome. Gastroenteorlogy. 116:1999;1035.
22. Miura M., Lawson D.C., Clary E.M., Mangel A.W., Pappas T.N. Central modulation of rectal distension-induced blood pressure changes by alosetron, a 5-HT, receptor antagonist. Dig Dis Sci. 44:1999;20-24.
23. Drossman D.A., Whitehead W.E., Camilleri M. Irritable bowel syndrome: a technical review for practice guideline development. Gastroenterology. 112:1997;2120-2137.
24. Silverman D., Munakata J., Mandelkern M., Hoh C., Mayer E. Comparing regional activity associated with visceral stimuli in male and female patients. J Nucl Med. 38:1997;237.
25. Degen L., Phillips S. Variability of gastrointestinal transit in healthy women and men. Gut. 39:1996;299-305.
26. Cook N., Sykes J., Davies G. Gender differences in bowel function. Digestion 59 (suppl 3). 1998;282.
27. Nguyen P., Lee S.D., Castell D.O. Evidence of gender differences in esophageal pain threshold. Am J Gastroenterol. 90:1995;901-905.