A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS

American Journal of Gastroenterology

Volumn 100, Issue 1, 2005, Pages 115-123

  Chang, Lin ^b   Ameen, Vanessa Z ^a   Dukes, George E ^b   McSorley, David J ^b   Carter, Eric G ^b   Mayer, Emeran A ^b  

^a GLAXOSMITHKLINE   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; PLACEBO; CARBOLINE DERIVATIVE; GASTROINTESTINAL AGENT;

ABDOMINAL PAIN; ADULT; ANUS CONTINENCE; ARTICLE; BLOATING; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEFECATION; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; HUMAN; INTESTINE MOTILITY; IRRITABLE COLON; MALE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; AGED; MIDDLE AGED; TREATMENT OUTCOME;

ABDOMINAL PAIN; ADULT; AGED; AGED, 80 AND OVER; CARBOLINES; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; GASTROINTESTINAL AGENTS; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 13744263696     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2005.40365.x     Document Type: Article

References (35)

1. Drossman DA, Camilleri M, Mayer EA, et al. AGA technical review on irritable bowel syndrome. Gastroenterology 2002;123(6):2108-31.
2. Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut 1999;45(Suppl 2):II43-7.
3. Drossman DA, Whitehead WE, Camilleri M. Irritable bowel syndrome. A technical review for practice guideline development. Gastroenterology 1997;112:2120-37.
4. Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology 2002;123(5):1686-701.
5. Berkley K. Sex differences in pain. Behav Brain Sci 1997;20:371-80.
6. Naliboff BD, Berman S, Chang L, et al. Sex-related differences in IBS patients: Central processing of visceral stimuli. Gastroenterology 2003;124(7):1738-47.
7. Mayer EA, Naliboff B, Lee O, et al. Review article: Gender-related differences in functional gastrointestinal disorders. Aliment Pharmacol Ther 1999;13(Suppl 2):65-9.
8. Riley JL 3rd, Robinson ME, Wise EA, et al. Sex differences in the perception of noxious experimental stimuli: A metaanalysis. Pain 1998;74(2-3):181-7.
9. Nakai A, Kumakura Y, Boivin M, et al. Sex differences of brain serotonin synthesis in patients with irritable bowel syndrome using alpha-[11C]methyl-L- tryptophan, positron emission tomography and statistical parametric mapping. Can J Gastroenterol 2003;17(3):191-6.
10. Evidence-based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol 2002;97(11 Suppl):S1-5.
11. Camilleri M, Northcutt AR, Kong S, et al. The efficacy and safety of alosetron in female patients with irritable bowel syndrome: A randomised, placebo controlled study. Lancet 2000;355:1035-40.
12. 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 1999;13:1149-51.
13. Camilleri M, Chey W, Mayer E, et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant IBS. Arch Intern Med 2001;161:1733-40.
14. Bardhan K, Bodemar G, Geldof 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 2000;14:23-24.
15. Lembo AJ, Olden KW, Ameen VZ, et al. Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome. Clin Gastroenterol Hepatol 2004;2(8):675-82.
16. Talley NJ, Zinsmeister AR, Melton LJ 3rd. Irritable bowel syndrome in a community: Symptom subgroups, risk factors, and health care utilization. Am J Epidemiol 1995;142(1):76-83.
17. Harding JP, Hamm LR, Ehsanullah R, et al. Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome. Aliment Pharmacol Ther 1997;11(6):1073-6.
18. Dunnett C. A multiple comparison procedure for comparing several treatments with a control. J Am Stat Assoc 1955;50:1096-121.
19. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of diseases. J Natl Cancer Inst 1959;22:719-48.
20. Mangel A, Northcutt A. Review article: The safety and efficacy of alosetron, a 5HT3 receptor antagonist, in female irritable bowel syndrome patients. Aliment Pharmacol Ther 1999;13(Suppl 2):77-82.
21. Houghton L, Foster J, Whorwell P. Alosetron, a 5-HT-3 receptor antagonist, delays colonic transit in patients with IBS and healthy volunteers. Aliment Pharmacol Ther 2000;14:775-82.
22. Viramontes BE, Camilleri M, McKinzie S, et al. Gender-related differences in slowing colonie transit by a 5-HT3 antagonist in subjects with diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol 2001;96(9):2671-6.
23. Delvaux M, Louvel D, Mamet JP, et al. Effect of alosetron on responses to colonic distension in patients with irritable bowel syndrome. Aliment Pharmacol Ther 1998;12(9):849-55.
24. 3 antagonist alosetron on basal and cholera toxin-induced secretion in the human jejunum: A segmental perfusion study. Aliment Pharmacol Ther 1997;11(6):1109-14.
25. Berman SM, Chang L, Suyenobu B, et al. Condition-specific deactivation of brain regions by 5-HT3 receptor antagonist alosetron. Gastroenterology 2002;123(4):969-77.
26. Koch KM, Palmer JL, Noordin N, et al. Sex and age differences in the pharmacokinetics of alosetron. Br J Clin Pharmacol 2002;53(3):238-42.
27. Koch KM, Corrigan BW, Manzo J, et al. Alosetron repeat dose pharmacokinetics, effects on enzyme activities, and influence of demographic factors. Aliment Pharmacol Ther 2004;20(2):223-30.
28. Bush TG, Spencer NJ, Watters N, et al. Effects of alosetron on spontaneous migrating motor complexes in murine small and large bowel in vitro. Am J Physiol Gastrointest Liver Physiol 2001;281(4):G974-83.
29. Camilleri M, Atanasova E, Carlson PJ, et al. Serotonin-transporter polymorphism pharmacogenetics in diarrhea-predominant irritable bowel syndrome. Gastroenterology 2002;123(2):425-32.
30. Berman S, Munakata J, Naliboff BD, et al. Gender differences in regional brain response to visceral pressure in IBS patients. Eur J Pain 2000;4(2):157-72.
31. Forster J, Houghton L, Whorwell P. Alosetron slows colonic transit in patients with irritable bowel syndrome. Gastroenterology 1997;112:A732.
32. Gore S, Gilmore IT, Haigh CG, et al. Colonic transit in man is slowed by ondansetron (GR38032F), a selective 5-hydroxytryptamine receptor (type 3) antagonist. Aliment Pharmacol Ther 1990;4(2):139-44.
33. 3 receptor antagonist, slows colonie transit in healthy man. Dig Dis Sci 1990;35(4):477-80.
34. Cremonini F, Delgardo-Aros S, Camilleri M. Efficacy of alosetron in irritable bowel syndrome: A meta-analysis of randomized controlled trials. Neurogastroenterol Motil 2003;15:79-86.
35. Wolfe SG, Chey WY, Washington MK, et al. Tolerability and safety of alosetron during long-term administration in female and male irritable bowel syndrome patients. Am J Gastroenterol 2001;96(3):803-11.