NCT06135389Not yet recruiting
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- Mar 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT06135389
What you commit to
- Study type: Observational
- Planned participants: 60
- From Mar 2025 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with medicinal products known to affect CYP2E1 or UGT (UDP glucuronosyltransferase): isoniazid, antiepileptic drugs (carbamazepine, phenytoin or phenobarbital), antiretroviral and tyrosine kinase inhibitors
Other illness
- History of chronic anaemia (≤ 5g/100ml)
- History of hepatocellular insufficiency (ASAT, ALAT ≥ 3N)
- History of renal impairment (\<60mL/min\*1.73m2)
- History of Gilbert's disease
- History of Type 2 diabetes
Other
- Major motor or neurological disability
- Intake of paracetamol within 24 hours before study inclusion (injection of paracetamol IV or oral intake)
Who the study is looking for
- Child aged 6 to 17 inclusive with normal weight for age and gender (body mass index \[BMI\]\<25kg/m2 adult equivalent at 18 years \[IOTF 25\]), overweight (body mass index \[BMI\]≥ 25kg/m2 adult equivalent at age 18 \[IOTF 25\] and obese (BMI ≥ 30kg/m2 adult equivalent at age 18 \[IOTF 30\]) for age and sex
- Surgical procedure requiring treatment with paracetamol intravenously as an analgesic
- No opposition by the holder(s) of parental authority
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert Debre University Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.