Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
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|ClinicalTrials.gov Identifier: NCT00434681|
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : July 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Fever Pain||Drug: paracetamol 4.8% paediatric oral suspension||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.|
|Study Start Date :||October 2006|
|Actual Study Completion Date :||April 2007|
- 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
- Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
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): NCT00434681
|Study Director:||Monique COUDERC, Dr||Sanofi|