Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Christian DUALE, Clinical Pharmacology Center, Inserm 1405, Clermont-Ferrand Hospital; Gilles DUCHEIX, Clinical Pharmacology Center, Inserm 1405, Clermont-Ferrand Hospital; Gisèle PICKERING, Clinical Pharmacology Center, Inserm 1405, Clermont-Ferrand Hospital
• Treatments: Acetaminophen; Acetylcysteine; N-monoacetylcystine

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