FeverPhase 3NCT00434681
Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
A Phase 3 study testing paracetamol 4.8% paediatric oral suspension in people with Fever and Pain, run by Sanofi at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 day to 8 years
- What is being tested?
- paracetamol 4.8% paediatric oral suspension
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
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
- Being tested
- paracetamol 4.8% paediatric oral suspension
- Medical subject headings
- Fever, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol 4.8% paediatric oral suspensionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startOct 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Monique COUDERC, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434681
- Sponsor's protocol ID
- PARAC_L_00859
- Status last verified
- Jul 2008
- First submitted
- 12 Feb 2007
- Last updated
- 21 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
- ClinicalTrials.gov ID
- NCT00434681
- Acronym / sponsor ID
- PARAC_L_00859
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracetamol 4.8% paediatric oral suspension | Drug | – |
Primary outcome
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
1 secondary outcome
Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique COUDERC, Dr study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paracetamol 4.8% paediatric oral suspension in people with Fever and Pain, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2008.