Placebo Effect of Paracetamol in Healthy Volunteers

NCT01053650 | Completed Phase 1

• 2 other identifiers: CHU-00652009-015610-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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..

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; Open / hidden; Placebo effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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,

Interventions

Paracetamol DRUG

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gisèle Pickering, MCU-PH

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 30, 2012

Record last verified: 2012-01

Locations

FR (1)