Paracetamol Study in Patients With Low Muscle Mass (NCT03648658) | Clinical Trial Compass
UnknownPhase 4
Paracetamol Study in Patients With Low Muscle Mass
Denmark48 participantsStarted 2019-02-18
Plain-language summary
To investigate the safety and toxicity related to paracetamol treatment in children and adults with respectively SMA and CP.
Who can participate
Age range6 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Patients: Men, women and children diagnosed with/biochemically verified SMA and CP
* Patients admitted to the ICU: Men, women, children diagnosed with/biochemically verified SMA and CP
* Healthy controls: Need to be healthy, evaluated by the investigator.
* Age:
* Children: 6-18 years
* Adult patients: 18-45 years
* Healthy controls: 18-45 years
* ICU-admitted patients: 6-45 years
* Signed informed consent to participation in the trial
Exclusion Criteria:
* \- Inability to understand the purpose of the trial or cooperate in the conduction of the experiments.
o For the children this will concern of course the parents or the guardians of the child.
* Competing conditions at risk for compromising the results of the study.
* Participation in other trials that may interfere with the results.
* Intake of medications that may interfere with the results, evaluated by investigator.
* Pregnancy and breastfeeding.
* BMI \>30\*
* In morbidly obese patients, the median area under the plasma concentration-time curve from 0 to 8 h. (AUC0-8h) of paracetamol is significantly smaller (p = 0.009), while the AUC0-8h ratios of the glucuronide, sulphate and cysteine metabolites to paracetamol are significantly higher (p = 0.043, 0.004 and 0.010, respectively). In this model, paracetamol CYP2E1-mediated clearance (cysteine and mercapturate) increased with lean body weight.