Paracetamol Study in Patients With Low Muscle Mass

Launched by METTE CATHRINE OERNGREEN · Aug 24, 2018

Keywords

ClinConnect Summary

This clinical trial, called the Paracetamol Study in Patients With Low Muscle Mass, is exploring the safety and potential side effects of using paracetamol (a common pain reliever) in children and adults with spinal muscular atrophy (SMA) type II and cerebral palsy (CP). The goal is to understand how this medication affects individuals with lower muscle mass and whether it's safe for them to use.

To participate in this study, individuals must be diagnosed with SMA or CP, and they can be children aged 6-18 or adults aged 18-45. Healthy volunteers in the same age range are also welcome to join. Participants will need to provide consent, and parents or guardians will need to sign for children. Those with certain health issues, pregnant or breastfeeding women, and individuals who are morbidly obese cannot participate. If you join the study, you can expect to be closely monitored to ensure your safety while taking paracetamol, and the research team will keep you informed throughout the process.

Gender

ALL

Eligibility criteria

• 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.