Fever, Pain
Conditions
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
Interventions
DRUGparacetamol 4.8% paediatric oral suspension
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 8 Years
Healthy volunteers
No
Inclusion criteria
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: * 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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2. | — |
Countries
France
Outcome results
None listed