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

Pain Clinical Trial

Official title:

Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434681
• Other study ID #: PARAC_L_00859
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2007
• Last updated: July 18, 2008
• Start date: October 2006
• Est. completion date: April 2007

Study information

• Verified date: July 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fever
• Pain

Intervention

Drug:
• paracetamol 4.8% paediatric oral suspension

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.