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Placebo Effect of Paracetamol in Healthy Volunteers (HOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053650
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : January 30, 2012
Information provided by (Responsible Party):
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..

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Paracetamol Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Placebo Effect of Paracetamol in Healthy Volunteers
Study Start Date : January 2010
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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

Primary Outcome Measures :
  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 Outcome Measures :
  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,

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053650

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

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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01053650    
Other Study ID Numbers: CHU-0065
2009-015610-22 ( EudraCT Number )
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 30, 2012
Last Verified: January 2012
Keywords provided by University Hospital, Clermont-Ferrand:
Healthy volunteers
Open / hidden
Placebo effect
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs