Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fever Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

paracetamol 4.8% paediatric oral suspension

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Monique COUDERC, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PARAC_L_00859

Identifier Type: -

Identifier Source: org_study_id