Placebo Effect of Paracetamol in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01053650
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Paracetamol is one of the most commonly used drugs in the world, indicated for the symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug used to relieve pain and reduce fever. The objective of this study is to analyze whether a placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of paracetamol is partly due to the simple fact of taking a drug.

Moreover, during the study you propose to do a saliva sample, optional, for biological research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your body..

Detailed Description

Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Healthy volunteers,

• Aged over 18 years and more than 50 years
• Males,
• Values of vital signs before administration of the test products:
• Systolic between 100-140 mm Hg
• diastolic between 50-90 mm Hg
• cardiac pulse between 45-90 beats per minute
• Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory)

Exclusion Criteria

• Contraindications to the administration of paracetamol : Hypersensitivity to paracetamol, History of hepatitis B or C, Severe renal impairment
• Hepatic insufficiency
• Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain,
• Pathology evolutionary time of the review of inclusion
• Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The main objective of this protocol is to assess the placebo effect in healthy volunteers by comparing pain thresholds and tolerance between two passages, when taking paracetamol.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of this study are 1 - explore, through testing Cantab ®, if the administration of paracetamol alter performance on cognitive tests. 2 - to analyze the determination of paracetamol and its metabolites in urine and blood samples,

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France