Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|