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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00434681
First received: February 12, 2007
Last updated: July 18, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Fever
Pain
Drug: paracetamol 4.8% paediatric oral suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Estimated Enrollment: 48
Study Start Date: October 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434681

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Monique COUDERC, Dr Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434681     History of Changes
Other Study ID Numbers: PARAC_L_00859
Study First Received: February 12, 2007
Last Updated: July 18, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 18, 2014