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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00434681 |
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 III |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%. |
| 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 |
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:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | PARAC_L_00859 |
| Study First Received: | February 12, 2007 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00434681 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |