Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
This study has been completed.
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First received: February 12, 2007
Last updated: July 18, 2008
Last verified: July 2008
Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric oral suspension in children weighing between 3 and 26 kg including limits
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Acceptability data: Overall evaluation of the treatment by the child's parents or the minder, measured using a semi-quantitative scale with 4 levels (very acceptable, acceptable, indifferent, refusal), for 24 hours (4 evaluations at 6 hour intervals).
- Safety data : Events reported by the child, parents or legal guardian during visit 2 ; events compiled in the child's diary ; events recorded by the investigator during Visit 2
Secondary Outcome Measures:
- Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2007|
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