Paracétamol PMB by Sublingual et Buccal Routes
Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal.
The per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route|
- Change in pain threshold testing mechanical stimulation (von Frey electronic) [ Time Frame: T0-5min, T0+3min, T0+7min, T0+15min, T0+30min, T0+50min, T0+90min ] [ Designated as safety issue: Yes ]
- Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire). [ Time Frame: T0+70min ] [ Designated as safety issue: Yes ]
- Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis) [ Time Frame: T0-10min ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Other: Von Frey electronic
Crossover study, double-blind, randomized, controlled versus placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206985
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Gisèle PICKERING||University Hospital, Clermont-Ferrand|