Last updated: 11/07/2018 18:35:39
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female 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 Study of Alosetron (GR68755) in Female Subjects With Irritable Bowel Syndrome
Trial description: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female 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:
A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome, Camilleri M, Chey WY, Mayer EA., Northcutt AR, et al., Arch Int Med 161: 1733-40, 2001
Alosetron Reduces Time Lost From Work in Women with Diarrhea-Predominant IBS: Data from Phase III Placebo-Controlled Clinical Trials, Jhingran P, Decker C, Watson M, Northcutt A, Ricci JFr, Clin Drug Invest 21 (12): 843-852 ,2001
Alosetron improves quality of life in women with diarrhea-predominant irritable bowel syndrome, Watson M, Lacey L, Kong S, et al, Am J Gastro 96 (2), 455-459, 2001
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
September 1997 to December 1998
Type
Not applicable
Phase
3
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
1998-22-12
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