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Paracetamol and Glutathion

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01116596
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Pain
Elderly
 Drug: Paracetamol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Paracetamol on the Status in Glutathione for the Aged Person

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Identify, by determining the concentration of blood GSH how the use of paracetamol at the doses usually prescribed affects the status of GSH [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116596

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01116596     History of Changes
Other Study ID Numbers: CHU-0072, 2006-006564-36
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Glutathione
Paracetamol
elderly people

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013