Paracétamol PMB by Sublingual et Buccal Routes

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: NCT01206985
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : January 30, 2012
Unither SA
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Von Frey electronic Phase 1

Detailed Description:
Crossover study, double-blind, randomized, controlled versus placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Intervention Details:
    Other: Von Frey electronic
    Change in pain threshold testing mechanical stimulation (von Frey electronic)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire). [ Time Frame: T0+70min ]
  2. Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis) [ Time Frame: T0-10min ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy volunteers.
  • Aged over 18 years and not more than 50 years.
  • Males or female
  • Values of vital signs before administration of the test products:
  • PAS between 100-140 mm Hg
  • PAD between 50-90 mm Hg
  • Radial pulse between 45-90 beats per minute
  • Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories

Exclusion Criteria:

  • Contraindications to the administration of paracetamol
  • 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 for inclusion.
  • Binge drinking, smoking (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
  • Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing.
  • Topic having all breaches of the oral mucosa (aphtes. ..).

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): NCT01206985

CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Unither SA
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01206985     History of Changes
Other Study ID Numbers: CHU-0081
2010-018746-30 ( EudraCT Number )
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by University Hospital, Clermont-Ferrand:
per-oral mucosa PMB
No disease, healthy volunteers

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs