Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever; Pain
Intervention: paracetamol 4.8% paediatric oral suspension (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Monique COUDERC, Dr, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
Study design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: 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: Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
Eligibility
Minimum age: N/A.
Maximum age: 8 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Paris, France
Additional Information
Starting date: October 2006
Ending date: January 2007
Last updated: October 15, 2007
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