Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.

Phase 3

Completed

• Conditions: Fever; Pain

• Registration Number: NCT00434681
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-13
• Study Completion: 2007-04
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-18
• Last Update Posted: 2008-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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).

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Exclusion Criteria

• 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.
• Who participated in another clinical study in the 30 days prior to inclusion.
• Is a relation of the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France