- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434681
Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Paris, France
- Sanofi-Aventis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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).
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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
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Secondary Outcome Measures
Outcome Measure |
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Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Monique COUDERC, Dr, Sanofi
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PARAC_L_00859
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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