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Title: Double-blind Study in Paediatric Epileptic Subjects Aged From 5 to Less Than 8 Years to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours      
available:
True
dateReleased:
12-20-2013
description:
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
privacy:
information not available
aggregation:
instance of dataset
ID:
NCT02021461
refinement:
curated
dateModified:
02-24-2014
availability:
available
types:
clinical trial
name:
Epilepsy
funders:
Bial - Portela C S.A.
selectionCriteria:
Inclusion Criteria: - A written informed consent form signed by the subject's parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects. - Male or female, between the age of 5 to <8 years. - Diagnosed with partial-onset epilepsy. - Is considered, in the opinion of the investigator, to be able to make the required taste assessment. Exclusion Criteria: - Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder. - Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants. - Strong congestion, flu, or any other acute illness that could influence the child's sense of taste. - A known swallowing or taste perception problem. - Currently or previously treated with ESL. - Concomitant participation in another drug clinical trial. - Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.
studyGroups:
ESL Banana taste
ESL Grape taste
ESL Tutti-Frutti taste
ID:
BIA-2093-212
types:
Interventional
accessURL: https://clinicaltrials.gov/ct2/show/results/NCT02021461
storedIn:
ClinicalTrial.gov
format:
HTML
accesstypes:
landing page
dateVerified:
20140201
authentication:
none
authorization:
none
creators:
Bial - Portela C S.A.
homepage: https://clinicaltrials.gov
ID:
SCR:002309
name:
ClinicalTrials.gov

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