Last updated: 11/07/2018 18:33:38
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Phase II Study to Assess the Clinical Efficacy of Alosetron (GR68755) in Male Subjects With Irritable Bowel Syndrome
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Phase II Study to Assess the Clinical Efficacy of Alosetron (GR68755) in Male Subjects With Irritable Bowel Syndrome
Trial description: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Phase II Study to Assess the Clinical Efficacy of Alosetron (GR68755) in Male Subjects With Irritable Bowel Syndrome
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
12-week randomized, double-blind, placebo-controlled, parallel,-group, dose-ranging, Phase II study to assess the clinical efficacy of alosetron in male subjects with IBS, Edwards EB, Heitman CK, Hall P, Hamedani AG, Dukes G, Mangel, Am J Gastro 96(9 supp 1): S317, 2001
Abstract: Gender differences in placebo response in patients with diarrhea-predominant irritable bowel syndrome (d-ibs). Ameen, V. Z. MD, Heath, A. T., and Chang, L. Digestive Disease Week 2005: American Association for the Study of Liver Diseases, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, Society for Surgery of the Alimentary Tract 5/15/2005 Chicago, IL; USA
Phase II Dose-ranging Study of Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant Irritable Bowel Syndrome, L Chang, V Ameen, G Dukes, D McSorley, E. Carter, E Mayer, Am J Gastro,100:115-123,2005
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
October 1999 to November 2000
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-16-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website