Paracetamol and Glutathion

NCT01116596 | Completed Phase 1

• 2 other identifiers: CHU-00722006-006564-36
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Elderly

Keywords

Glutathione; Paracetamol; elderly people

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Paracetamol DRUG

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 Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject to compliance with the prescribed drug therapy is questionable.
• Subject taking the N-acetyl-cysteine.
• Renal or hepatic disease.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

FR (1)