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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: | 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%. |
| 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
| 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 - French Health Products Safety Agency |
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Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |