Chronic PainPhase 1NCT01116596
Paracetamol and Glutathion
A Phase 1 study testing Paracetamol in people with Chronic Pain and Elderly, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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)). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Elderly
- What is being tested?
- Paracetamol
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Subject to compliance with the prescribed drug therapy is questionable.
- Subject taking the N-acetyl-cysteine.
- Renal or hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Paracetamol on the Status in Glutathione for the Aged Person
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.
Read the 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.
- Conditions
- Chronic Pain, Elderly
- Being tested
- Paracetamol
- Keywords
- Glutathione, Paracetamol, elderly people
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116596
- Sponsor's protocol ID
- CHU-0072
- Other IDs
- 2006-006564-36
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol on the Status in Glutathione for the Aged Person
- ClinicalTrials.gov ID
- NCT01116596
- Acronym / sponsor ID
- CHU-0072
- Conditions
- Chronic Pain, Elderly
- Keywords
- Glutathione, Paracetamol, elderly people
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Subject to compliance with the prescribed drug therapy is questionable.
- Subject taking the N-acetyl-cysteine.
- Renal or hepatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamoldetermine, 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. | Drug | – |
Primary outcome
Identify, by determining the concentration of blood GSH how the use of paracetamol at the doses usually prescribed affects the status of GSH
1 secondary outcome
Quantifying the loss of cysteine for detoxification of acetaminophen by measuring the amount of paracetamol cysteine conjugate and mercapturic acid excreted in urine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paracetamol in people with Chronic Pain and Elderly, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify, by determining the concentration of blood GSH how the use of paracetamol at the doses usually prescribed affects the status of GSH. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010; AzTrials last refreshed its copy on 30 Oct 2026.