Paracetamol Study in Patients With Low Muscle Mass

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and toxicity related to paracetamol treatment in children and adults with respectively SMA and CP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mette Cathrine Oerngreen
• Collaborator: Elsass Foundation
• Treatments: Acetaminophen

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.