Paracetamol and Glutathion

Phase 1

Completed

• Conditions: Chronic Pain; Elderly

• Registration Number: NCT01116596
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-05
• Status Verified: 2010-05
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Last Update Submitted: 2010-05-04
• Study First Posted: 2010-05-05
• Last Update Posted: 2010-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France