Placebo Effect of Paracetamol in Healthy Volunteers

Healthy Volunteers Clinical Trial

— HOP  

Official title:

Placebo Effect of Paracetamol in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053650
• Other study ID #: CHU-0065
• Secondary ID: 2009-015610-22
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2010
• Last updated: January 26, 2012
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: January 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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..

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Paracetamol
Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			Yes
Secondary	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,			Yes