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paracetamol 4.8% paediatric

Phase 3

Fever | Small molecule | Infectious Disease |Sanofi|Trials Updated: Jul 21, 2008

paracetamol 4.8% paediatric target and mechanism

ModalitySmall molecule

Also known as paracetamol 4.8% paediatric oral suspension

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

paracetamol 4.8% paediatric clinical trials

paracetamol 4.8% paediatric · 1 trial · 2 indications

Phase 3 1
NCT00434681Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.Fever
COMPLETED48 Analytics
PHASE3COMPLETED
Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
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Study Endpoints

Primary Endpoints

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 Endpoints

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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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Interventions

NameTypeDescription
paracetamol 4.8% paediatric oral suspensionDRUG -
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Eligibility Criteria

Age Range1 Day to 8 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 po...

Countries:France
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Frequently asked questions about paracetamol 4.8% paediatric

What is paracetamol 4.8% paediatric?

Paracetamol 4.8% paediatric is an oral suspension formulation of paracetamol developed by Sanofi for use in children. It is being studied for fever, with the trial also listing pain as a condition. The product is a small molecule medicine given as a paediatric oral suspension.

What is paracetamol 4.8% paediatric used for?

Paracetamol 4.8% paediatric is used for fever in children, and the clinical trial for this formulation also listed pain as a condition. It is an oral suspension, a liquid dose form intended for paediatric patients, including very young infants based on the trial's minimum age of one day.

Who makes paracetamol 4.8% paediatric?

Sanofi develops paracetamol 4.8% paediatric. Sanofi trades under the ticker SNY. The company is the sponsor behind the clinical development of this paediatric oral suspension formulation.

What phase is paracetamol 4.8% paediatric in?

Paracetamol 4.8% paediatric is in Phase 3 development. It is an investigational formulation and is not described as approved. One Phase 3 trial has been completed, and no trials for this formulation are currently active.

What clinical trials is paracetamol 4.8% paediatric in?

Paracetamol 4.8% paediatric has been studied in one completed Phase 3 trial, NCT00434681, titled Paracetamol Oral Paediatric Suspension at 4.8%: Study of Acceptability and Safety. The trial enrolled 48 participants in France, included both sexes, and accepted patients from one day of age.

Is paracetamol 4.8% paediatric the same as paracetamol 4.8% paediatric oral suspension?

Yes, paracetamol 4.8% paediatric is also known as paracetamol 4.8% paediatric oral suspension. Both names refer to the same Sanofi product, a liquid oral suspension formulation of paracetamol at a 4.8% concentration developed for paediatric use in fever.