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paracetamol 4.8% paediatric

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

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.
Fever
NCT0043468148
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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 used for?

Paracetamol 4.8% paediatric is a small molecule drug being developed by Sanofi for the treatment of fever. It is formulated as an oral paediatric suspension at a 4.8% concentration. The drug is currently in Phase 3 clinical development and is intended for use in paediatric patients.

Who makes paracetamol 4.8% paediatric?

Sanofi (ticker: SNY) is the developer of paracetamol 4.8% paediatric. The company is conducting clinical trials to evaluate the acceptability and safety of this oral paediatric suspension for the treatment of fever in children.

What phase is paracetamol 4.8% paediatric in?

Paracetamol 4.8% paediatric is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 48 participants, to assess its acceptability and safety.

What clinical trials is paracetamol 4.8% paediatric in?

Paracetamol 4.8% paediatric has one completed Phase 3 clinical trial registered under NCT00434681. The trial, titled "Paracetamol Oral Paediatric Suspension at 4.8%: Study of Acceptability and Safety," enrolled 48 participants in France and evaluated the drug for fever and pain.

Is paracetamol 4.8% paediatric the same as paracetamol?

Paracetamol 4.8% paediatric is a specific formulation of paracetamol, also known as acetaminophen, designed for paediatric use. It is an oral suspension with a 4.8% concentration, developed by Sanofi for treating fever in children. This formulation is distinct from other paracetamol products due to its concentration and paediatric focus.