Last updated: 11/07/2018 18:36:00
A 12-Month Randomized, Double-blind, Placebo-controlled Study to Evaluate the Quality of Life and Safety Associated with the Long-term Use of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome (Final Analysis)
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-Month Randomized, Double-blind, Placebo-controlled Study to Evaluate the Quality of Life and Safety Associated with the Long-term Use of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome (Final Analysis)
Trial description: A 12-Month Randomized, Double-blind, Placebo-controlled Study to Evaluate the Quality of Life and Safety Associated with the Long-term Use of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome (Final Analysis)
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:
Tolerability of the 5HT3 Receptor Antagonist Alosetron Following Long-Term Administration in Female and Male Irritable Bowel Syndrome Patients, Wolfe S, Chey W, Washington MK, et al, Am J Gastroenterology 96(3) 803-11, 2001
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
November 1997 to October 1999
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
1999-04-10
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
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