Paracetamol and Glutathion
Primary Purpose
Chronic Pain, Elderly
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Glutathione, Paracetamol, elderly people
Eligibility 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.
Sites / Locations
- CHU Clermont-Ferrand
Outcomes
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
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
Full Information
NCT ID
NCT01116596
First Posted
May 4, 2010
Last Updated
May 4, 2010
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01116596
Brief Title
Paracetamol and Glutathion
Official Title
Effect of Paracetamol on the Status in Glutathione for the Aged Person
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Elderly
Keywords
Glutathione, Paracetamol, elderly people
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Paracetamol and Glutathion
We'll reach out to this number within 24 hrs