Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
|ClinicalTrials.gov Identifier: NCT00745004|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : January 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome With Diarrhoea||Drug: Ondansetron Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D): Identifying the "Responder"|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days.
Over-encapsulated 4mg ondansetron tablets. Ondansetron 4mg OD, dose titrated up to a maximum of 8mg tds or down to a minimum of 4mg alternate days. For 5 weeks.
Placebo Comparator: 2
Placebo 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days.
Capsule matching over-encapsulated experimental drug. 1 capsule OD, dose titrated up to a maximum of 2 capsules tds or down to a minimum of 1 capsule alternate days. For 5 weeks.
- The primary outcome measure is the difference in average stool consistency during the last two week period of Ondansetron compared to placebo treatment. [ Time Frame: 2 weeks ]
- 1) Proportion of patients preferring ondansetron versus placebo 2) Proportion wanting to continue with ondansetron versus placebo 3) Difference between ondansetron and placebo periods. [ Time Frame: Duration of study and post-study analysis ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745004
|University Hospital of South Manchester NHS Foundation Trust|
|Manchester, Greater Manchester, United Kingdom, M23 9LT|
|University of Nottingham|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Principal Investigator:||Robin Spiller||University of Nottingham|
|Principal Investigator:||Peter Whorwell, MD||Manchester University NHS Foundation Trust|