Placebo Effect of Paracetamol in Healthy Volunteers

NCT ID: NCT01053650

Last Updated: 2012-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-02-28

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Paracetamol

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

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle Pickering, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2009-015610-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CHU-0065

Identifier Type: -

Identifier Source: org_study_id