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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Fever; Pain

Treatments: Drug: paracetamol 4.8% paediatric oral suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434681

PARAC_L_00859

Details and patient eligibility

About

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

Sex: All

Ages: 1 day to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.