Paracetamol Study in Patients With Low Muscle Mass

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT03648658
• Date of registration: 08/08/2018
• Prospective Registration: Yes
• Primary sponsor: Mette Cathrine Oerngreen
• Public title: Paracetamol Study in Patients With Low Muscle Mass
• Scientific title: Pharmacokinetics and Safety of Treatment With Paracetamol in Children and Adults With Spinal Muscular Atrophy and Cerebral Palsy
• Date of first enrolment: February 18, 2019
• Target sample size: 48
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03648658
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Mette Cathrine Ørngreen, MD, DMsc

• Name: Mette Cathrine Ørngreen, MD, DMSc

• Name: Mette Cathrine Ørngreen, MD, DMSc
• Affiliation: MD

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

SMA II

Cerebral Palsy

Intervention(s)

Drug: Paracetamol 120Mg/5mL Oral Suspension

Primary Outcome(s)

Clearance paracetamol [Time Frame: Three days]

Volume of distribution of paracetamol [Time Frame: Three days]

Secondary Outcome(s)

Concentration-time data on liver function and paracetamolparametres [Time Frame: Three days]

Liver function tests: ALT, AST, LDH, Alkaline Phosphatase, Bilirubin (U/L) [Time Frame: Three days]

Secondary ID(s)

08-06-2018-paracet

2018-002295-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Elsass Foundation