Chronic Pain Clinical Trial
Official title:
Effect of Paracetamol on the Status in Glutathione for the Aged Person
| Verified date | May 2010 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | May 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Identify, by determining the concentration of blood GSH how the use of paracetamol at the doses usually prescribed affects the status of GSH | Yes | ||
| Secondary | Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine | Yes |
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