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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434681
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : July 21, 2008
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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

Condition or disease Intervention/treatment Phase
Fever Pain Drug: paracetamol 4.8% paediatric oral suspension Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
Study Start Date : October 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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).
  2. 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 Measures :
  1. Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434681

Paris, France
Sponsors and Collaborators
Study Director: Monique COUDERC, Dr Sanofi Identifier: NCT00434681     History of Changes
Other Study ID Numbers: PARAC_L_00859
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs