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Paracetamol and Glutathion

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ClinicalTrials.gov Identifier: NCT01116596
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : May 5, 2010
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:

Paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (Glutathione (GSH)). Medications such as paracetamol, may reduce the reserves of GSH because it is used for detoxification and elimination. It is well known that the concentration of GSH decrease after administration of paracetamol in humans and animals.

Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly, a decrease of GSH concentration in plasma or red blood cells is associated with decreased physical and mental health.

We wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.


Condition or disease Intervention/treatment Phase
Chronic Pain Elderly Drug: Paracetamol Phase 1

Detailed Description:

Paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (glutathione (GSH)). Medications such as paracetamol, may reduce the reserves of GSH because it is used for detoxification and elimination. It is well known that the concentration of GSH decrease after administration of paracetamol in humans and animals.

Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly, a decrease of GSH concentration in plasma or red blood cells is associated with decreased physical and mental health.

We wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Paracetamol on the Status in Glutathione for the Aged Person
Study Start Date : February 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arms and Interventions
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Intervention Details:
  • Drug: Paracetamol
    determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.

Outcome Measures
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Primary Outcome Measures :
  1. Identify, by determining the concentration of blood GSH how the use of paracetamol at the doses usually prescribed affects the status of GSH

Secondary Outcome Measures :
  1. Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elderly patients over 70 years and treated for over two weeks by oral paracetamol, 3 grams per day (Doliprane ® 1000 mg) as part of their usual care.
  • Male and female.

Exclusion Criteria:

  • Subject to compliance with the prescribed drug therapy is questionable.
  • Subject taking the N-acetyl-cysteine.
  • Renal or hepatic disease.
Contacts and Locations
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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): NCT01116596


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
More Information
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Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01116596    
Other Study ID Numbers: CHU-0072
2006-006564-36 ( EudraCT Number )
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 2010
Keywords provided by University Hospital, Clermont-Ferrand:
Glutathione
Paracetamol
elderly people
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics