HealthyPhase 1PANACENCT02206178
Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine
A Phase 1 study testing N-acetylcysteine combination with acetaminophen in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain. The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- N-acetylcysteine combination with acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jan 2014
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Between 18 and 45 years old
- Without treatment during the 7 days before inclusion specially no use of antalgic and anti-inflammatory
- Cooperation and understanding enough to conform to the study obligations -Having given free, informed written consent
- Affiliated at system of French social security
- Inscription or acceptation of inscription in the national register of volunteers involved in trials.
Who cannot join
- Patient with one or many contraindication for the administration of the trial's products,
- Patient that have taken N-acetylcysteine as bronchial thinner during the last 3 days,
- Patient with medical or surgical history judged by the investigator or his representative as being not compatible with the clinical trial
- Patient with disease progression during inclusion,
- Patient with excessive consumption of alcohol, tobacco (+ than 10 cigarette/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cup a day) or any addiction to drugs,
- Patient with a heat pain mean threshold during training higher or equal to 46.5°C,
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- Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial,
- Patient with cooperation and understanding that do not allow him to follow the trial,
- Patients with minor or under guardianship,
- No affiliation at system of French social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE
Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain.
The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.
The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
- - decrease the antinociceptive effect of acetaminophen in comparison to a group control
- - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme.
Read the detailed description
Period 1 : To Day -4 to Day 0
Day -4 at 8:00 am at Clinical Pharmacology Center
- Inclusion Visit, signature of Informed consent form, clinical exam.
- Training test
- Blood sample (GSH, pharmacogenetic, Biochemistry assay)
- Randomization and attribution of treatment for the fisrt study period at home: (day -4, -3, -2, -1) 4 days of oral acetaminophen and [N-acetylcysteine or placebo] according to the randomization plan.
At day -3, -2 and -1 a salivary sample will be done to control the treatment compliance.
Day 0 at Clinical Pharmacology Center Clinical examination Measurement of the basal pain thresholds and pain evaluation (Visual Analog Scales) Blood and urinary sample (acetaminophen and GSH assay)
T0 : Administration of product: acetaminophen and [N-acetylcysteine or placebo]
T0+1H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+2H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood sample (acetaminophen assay)
T0+3H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+4H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood and urinary sample (acetaminophen, GSH, biochemistry assay)
- Lunch before departure
2 weeks of wash-out
Period 2 : To Day 17 to Day 21
Same of period 1. Subject who receives N-acétylcystéine in period 1 will receive placebo in second period and vice versa.
- Conditions
- Healthy
- Being tested
- N-acetylcysteine combination with acetaminophen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine combination with acetaminophenDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| acetaminophen | Experimental | The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.
The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control
2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme Receives: Drug: N-acetylcysteine combination with acetaminophen |
| placebo | Placebo comparator | 1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control
2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme Receives: Drug: N-acetylcysteine combination with acetaminophen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration (T0+1h, T0+2h, T0+3h, T0+4h).
Measured: At day 0
Secondary outcomes (4)
Blood glutathione GSH concentration
Blood glutathione GSH concentration at J0 T0-1h and J0 T0+4h
Measured: At day 0
Blood of acetaminophen concentration and its metabolites
Blood of acetaminophen concentration and its metabolites at J0 T0-1h, T0+2h, and T0+4h.
Measured: at day 0
Urinary assay of the rate of acetaminophen and its metabolites
Urinary assay of the rate of acetaminophen and its metabolites at J0 T0-1h, and T0+4h.
Measured: at day 0
Pharmacogenetic dosage of enzymes involved in glutathione metabolism
Measured: at day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206178
- Sponsor's protocol ID
- CHU-0202
- Other IDs
- 2013-000668-27
- Acronym
- PANACE
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2014
- Last updated
- 7 Aug 2026
- Results posted
- No
Publications
Pickering G, Macian N, Papet I, Duale C, Coudert C, Pereira B. N-acetylcysteine prevents glutathione decrease and does not interfere with paracetamol antinociceptive effect at therapeutic dosage: a randomized double-blind controlled trial in healthy subjects. Fundam Clin Pharmacol. 2019 Jun;33(3):303-311. doi: 10.1111/fcp.12437. Epub 2019 Jan 2.
PubMed 30471141
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE
- ClinicalTrials.gov ID
- NCT02206178
- Acronym / sponsor ID
- PANACE / CHU-0202
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Aug 2014 (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.
Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain.
The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.
The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
- - decrease the antinociceptive effect of acetaminophen in comparison to a group control
- - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme.
Detailed description
Period 1 : To Day -4 to Day 0
Day -4 at 8:00 am at Clinical Pharmacology Center
- Inclusion Visit, signature of Informed consent form, clinical exam.
- Training test
- Blood sample (GSH, pharmacogenetic, Biochemistry assay)
- Randomization and attribution of treatment for the fisrt study period at home: (day -4, -3, -2, -1) 4 days of oral acetaminophen and [N-acetylcysteine or placebo] according to the randomization plan.
At day -3, -2 and -1 a salivary sample will be done to control the treatment compliance.
Day 0 at Clinical Pharmacology Center Clinical examination Measurement of the basal pain thresholds and pain evaluation (Visual Analog Scales) Blood and urinary sample (acetaminophen and GSH assay)
T0 : Administration of product: acetaminophen and [N-acetylcysteine or placebo]
T0+1H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+2H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood sample (acetaminophen assay)
T0+3H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+4H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood and urinary sample (acetaminophen, GSH, biochemistry assay)
- Lunch before departure
2 weeks of wash-out
Period 2 : To Day 17 to Day 21
Same of period 1. Subject who receives N-acétylcystéine in period 1 will receive placebo in second period and vice versa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetaminophen | Experimental | Drug: N-acetylcysteine combination with acetaminophenThe purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine. The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine 1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control 2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme |
| placebo | Placebo comparator | Drug: N-acetylcysteine combination with acetaminophen, Drug: Placebo1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control 2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Between 18 and 45 years old
- Without treatment during the 7 days before inclusion specially no use of antalgic and anti-inflammatory
- Cooperation and understanding enough to conform to the study obligations -Having given free, informed written consent
- Affiliated at system of French social security
Key exclusion criteria (10 listed)
- Patient with one or many contraindication for the administration of the trial's products,
- Patient that have taken N-acetylcysteine as bronchial thinner during the last 3 days,
- Patient with medical or surgical history judged by the investigator or his representative as being not compatible with the clinical trial
- Patient with disease progression during inclusion,
- Patient with excessive consumption of alcohol, tobacco (+ than 10 cigarette/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cup a day) or any addiction to drugs,
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 |
|---|---|---|
| N-acetylcysteine combination with acetaminophen | Drug | acetaminophen, placebo |
| Placebo | Drug | placebo |
Primary outcome
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration
Time frame: At day 0
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration (T0+1h, T0+2h, T0+3h, T0+4h).
4 secondary outcomes
Blood glutathione GSH concentration
Time frame: At day 0
Blood of acetaminophen concentration and its metabolites
Time frame: at day 0
Urinary assay of the rate of acetaminophen and its metabolites
Time frame: at day 0
Pharmacogenetic dosage of enzymes involved in glutathione metabolism
Time frame: at day 4
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 7 Aug 2026.
- Results publication: PubMed 30471141Pickering G, Macian N, Papet I, Duale C, Coudert C, Pereira B. N-acetylcysteine prevents glutathione decrease and does not interfere with paracetamol antinociceptive effect at therapeutic dosage: a randomized double-blind controlled trial in healthy subjects. Fundam Clin Pharmacol. 2019 Jun;33(3):303-311. doi: 10.1111/fcp.12437. Epub 2019 Jan 2.
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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 N-acetylcysteine combination with acetaminophen in people with Healthy, 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 6 inclusion and 10 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 7 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206178, which also lists 1 linked publication.
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 7 Aug 2026.