Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety. (NCT00434681)

Study 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

Conditions studied

Fever
Pain

In context

Lead sponsor

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Who can participate

Ages eligible: 1 Day to 8 Years
Sexes eligible: All
Accepts healthy volunteers: No

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion criteria

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).

Exclusion criteria

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.

Study design

Phase: Phase 3
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 48 participants

Interventions

Drugparacetamol 4.8% paediatric oral suspension

What researchers measure

Primary outcomes

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

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

Study locations

1 site

Sanofi-Aventis
Paris, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00434681
Lead sponsor: Sanofi
First posted: Feb 13, 2007
Start date: Oct 2006
Completion: Apr 2007
Last update: Jul 21, 2008

Study contacts

Monique COUDERC, Dr

study director · Sanofi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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