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Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine (PANACE)

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ClinicalTrials.gov Identifier: NCT02206178
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: N-acetylcysteine combination with acetaminophen Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE
Study Start Date : September 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acetaminophen

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
Drug: N-acetylcysteine combination with acetaminophen
Placebo Comparator: placebo
  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
Drug: N-acetylcysteine combination with acetaminophen
Drug: Placebo



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Blood glutathione GSH concentration [ Time Frame: At day 0 ]
    Blood glutathione GSH concentration at J0 T0-1h and J0 T0+4h

  2. Blood of acetaminophen concentration and its metabolites [ Time Frame: at day 0 ]
    Blood of acetaminophen concentration and its metabolites at J0 T0-1h, T0+2h, and T0+4h.

  3. Urinary assay of the rate of acetaminophen and its metabolites [ Time Frame: at day 0 ]
    Urinary assay of the rate of acetaminophen and its metabolites at J0 T0-1h, and T0+4h.

  4. Pharmacogenetic dosage of enzymes involved in glutathione metabolism [ Time Frame: at day 4 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206178


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02206178     History of Changes
Other Study ID Numbers: CHU-0202
2013-000668-27
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Acetaminophen
Acetylcysteine
N-monoacetylcystine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes