Placebo Effect of Paracetamol in Healthy Volunteers (HOP)
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..
|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|
- 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 ]
- 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 ]
|Study Start Date:||January 2010|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053650
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Gisèle Pickering, MCU-PH||University Hospital, Clermont-Ferrand|