Skip to main content
OpenTrials
Completed

NCT Number: NCT01206985

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. ..).

Treatment and study plan

Von Frey electronic

Other

Change in pain threshold testing mechanical stimulation (von Frey electronic)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Unither SA

Registry information

Official study title

Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 22, 2010
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.