Paracétamol PMB by Sublingual et Buccal Routes

This study has been completed.
Sponsor:
Collaborator:
Unither SA
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01206985
First received: September 6, 2010
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Healthy Volunteers
Other: Von Frey electronic
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Von Frey electronic
    Change in pain threshold testing mechanical stimulation (von Frey electronic)
Detailed Description:

Crossover study, double-blind, randomized, controlled versus placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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. ..).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206985

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

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01206985     History of Changes
Other Study ID Numbers: CHU-0081, 2010-018746-30
Study First Received: September 6, 2010
Last Updated: January 26, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 18, 2014