NCT00434681CompletedPhase 3
Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Outcomes
Primary Outcomes
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
- Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Acceptability study of a new paediatric formulation of Orphacol® (cholic acid) in paediatric patients treated for inborn errors in primary bile acid synthesis due to 3ß-Hydroxy-?5-C27- steroid oxidoreductase deficiency or ?4-3-Oxosteroid-5ß-reductase deficiency.K76.8Other specified diseases of liverDRKS00013645aboratoires CTRS4
Completed
Phase 1
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)Acute PainNCT05406752Unither Pharmaceuticals, France32
Completed
Phase 1
A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult SubjectsPainNCT05022810HALEON61
Completed
Not Applicable
New Paediatric Formulation of Tachipirina®HealthyNCT06358586Aziende Chimiche Riunite Angelini Francesco S.p.A20
Not yet recruiting
Phase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric PatientsEdema Due to Heart Failure or CirrhosisNCT06021860CMP Development, LLC96