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Paracetamol Study in Patients With Low Muscle Mass

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ClinicalTrials.gov Identifier: NCT03648658
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Elsass Foundation
Information provided by (Responsible Party):
Mette Cathrine Oerngreen, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
SMA II Cerebral Palsy Drug: Paracetamol 120Mg/5mL Oral Suspension Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Safety of Treatment With Paracetamol in Children and Adults With Spinal Muscular Atrophy and Cerebral Palsy
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Paracetamol 15mg/kg Drug: Paracetamol 120Mg/5mL Oral Suspension
The subjects will be treated with paracetamol in therapeutic doses, 15mg/kg/dose every six hour, with a maximum dosage of 1 g x 4 per day, for three consecutive days.




Primary Outcome Measures :
  1. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  2. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (total paracetamol) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  3. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (glucuronidation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  4. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (sulphation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  5. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (CYP2E1 oxidation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  6. Clearance paracetamol [ Time Frame: Three days ]
    - Clearance (unchanged paracetamol) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

  7. Volume of distribution of paracetamol [ Time Frame: Three days ]
    - Volume of distribution of paracetamol in patients with SMA, CP and ICU-admitted patients with SMA or CP, in comparison with healthy controls.


Secondary Outcome Measures :
  1. Liver function tests: ALT, AST, LDH, Alkaline Phosphatase, Bilirubin (U/L) [ Time Frame: Three days ]
    - Liver function tests in patients with SMA, CP and ICU-admitted patients with SMA or CP.: ALT, AST, LDH, Alkaline Phosphatase, Bilirubin (U/L)

  2. Concentration-time data on liver function and paracetamolparametres [ Time Frame: Three days ]
    - Concentration-time data on plasma paracetamol, paracetamol-sulphate, paracetamol-glucuronide, paracetamol-cysteine and paracetamol-mercapturate (oxidative metabolites), plasma-glutathione and liver biomarkers (ALAT, PP, bilirubin, MicroRNA-122 (miR-122)).



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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648658


Contacts
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Contact: Mette Cathrine Ørngreen, MD, DMSc +45 35 45 76 14 mette.cathrine.oerngreen.01@regionh.dk

Locations
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Denmark
Copenhagen Neuromuscular Center Recruiting
Copenhagen, Denmark, 2200
Contact: Mette Cathrine Ørngreen, MD, DMsc    004535457614    mette.cathrine.oerngreen.01@regionh.dk   
Principal Investigator: Mette Cathrine Ørngreen, MD, DMsc         
Sponsors and Collaborators
Mette Cathrine Oerngreen
Elsass Foundation
Investigators
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Principal Investigator: Mette Cathrine Ørngreen, MD, DMSc MD

Publications:
Sen, C. K. Glutathione: A key role in skeletal muscle metabolism. in Oxidative Stress in Skeletal Muscle 127-139 (Birkhäuser, Basel, 1998). doi:10.1007/978-3-0348-8958-2_8

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Responsible Party: Mette Cathrine Oerngreen, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03648658     History of Changes
Other Study ID Numbers: 08-06-2018-paracet
2018-002295-40 ( EudraCT Number )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics