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

28. juli 2016 opdateret af: University Hospital, Clermont-Ferrand

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

  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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig, 63003
        • CHU de Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: N-acetylcysteine combination with acetaminophen
Placebo komparator: 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
Medicin: Placebo
Medicin: N-acetylcysteine combination with acetaminophen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration
Tidsramme: 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).
At day 0

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood glutathione GSH concentration
Tidsramme: At day 0
Blood glutathione GSH concentration at J0 T0-1h and J0 T0+4h
At day 0
Blood of acetaminophen concentration and its metabolites
Tidsramme: at day 0
Blood of acetaminophen concentration and its metabolites at J0 T0-1h, T0+2h, and T0+4h.
at day 0
Urinary assay of the rate of acetaminophen and its metabolites
Tidsramme: at day 0
Urinary assay of the rate of acetaminophen and its metabolites at J0 T0-1h, and T0+4h.
at day 0
Pharmacogenetic dosage of enzymes involved in glutathione metabolism
Tidsramme: at day 4
at day 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

29. juli 2014

Først indsendt, der opfyldte QC-kriterier

31. juli 2014

Først opslået (Skøn)

1. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHU-0202
  • 2013-000668-27

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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