Status:
COMPLETED
Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 acetamino...
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, pharmacogen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02206178
Start Date
September 1 2013
End Date
January 1 2014
Last Update
July 29 2016
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003