Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
1 other identifier
interventional
48
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJuly 21, 2008
July 1, 2008
February 12, 2007
July 18, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
Interventions
Eligibility Criteria
You may qualify if:
- Children of both sexes weighing between 3 and 26 kg including limits.
- With a fever and/or painful episode justifying a paracetamol treatment for a minimum duration of 24 hours.
- Likely to be followed throughout the entire study period in out-patient.
- For whom the informed consent has been signed by the parents or legal guardian and by the child if old enough (see chapter 12.3).
You may not qualify if:
- Presenting digestive disorders, vomiting.
- Presenting a hypersensitivity to paracetamol or one of the ingredients of the study product
- Presenting a hepatocellular failure.
- Presenting a fructose intolerance.
- Presenting a serious concomitant disease, such as cancer, immune deficiency or a serious renal, hepatic cardiac, neurological, psychiatric or metabolic disease.
- Presenting a history of significant biological anomalies.
- Treated with Kayexalate® (sodium polystyrene sulphonate)
- Not covered by a social security regime.
- Whose parents are incapable of understanding
- Who cannot come back to the consultation for the final evaluation and/or submit to the study constraints.
- Is a relation of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Monique COUDERC, Dr
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 13, 2007
Study Start
October 1, 2006
Study Completion
April 1, 2007
Last Updated
July 21, 2008
Record last verified: 2008-07