NCT02206178

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. 1.\- decrease the antinociceptive effect of acetaminophen in comparison to a group control
  2. 2.\- and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

July 29, 2014

Last Update Submit

July 28, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (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

    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

Secondary Outcomes (4)

  • Blood glutathione GSH concentration

    At day 0

  • Blood of acetaminophen concentration and its metabolites

    at day 0

  • Urinary assay of the rate of acetaminophen and its metabolites

    at day 0

  • Pharmacogenetic dosage of enzymes involved in glutathione metabolism

    at day 4

Study Arms (2)

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

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

Drug: N-acetylcysteine combination with acetaminophenDrug: Placebo

Interventions

N-acetylcysteine combination with acetaminophenDRUG
acetaminophenplacebo
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Between 18 and 45 years old
  • 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.

You may not qualify if:

  • 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 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 1, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

FR(1)