Paracetamol Oral Paediatric Suspension at 4.8% : Study of... | NCT00434681

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

NCT00434681

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 21, 2008Estimated

Enrollment

Phase

Phase 3

Conditions

Fever
Pain

Interventions

paracetamol 4.8% paediatric oral suspension

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Feb 12, 2007

First Submission Date that Met QC Criteria

Feb 12, 2007

First Posted Date

Feb 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2008

Last Update Posted Date

Jul 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
paracetamol 4.8% paediatric oral suspension	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

ID	Term
D005334	Fever
D010146	Pain