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Placebo Effect of Paracetamol in Healthy Volunteers (HOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01053650
First received: January 19, 2010
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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..


Condition Intervention Phase
Healthy Volunteers
 Drug: Paracetamol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Placebo Effect of Paracetamol in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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, [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paracetamol
    Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053650

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Gisèle Pickering, MCU-PH University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01053650     History of Changes
Other Study ID Numbers: CHU-0065, 2009-015610-22
Study First Received: January 19, 2010
Last Updated: January 26, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Healthy volunteers
Open / hidden
Placebo effect

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013