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

28. juli 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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
Legemiddel: Placebo
Legemiddel: N-acetylcysteine combination with acetaminophen

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Clermont-Ferrand

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2013

Primær fullføring (Faktiske)

1. januar 2014

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

29. juli 2014

Først innsendt som oppfylte QC-kriteriene

31. juli 2014

Først lagt ut (Anslag)

1. august 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHU-0202
  • 2013-000668-27

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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