Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa (PMB)

This study has been completed.
Sponsor:
Collaborator:
Unither Pharmaceuticals
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00982215
First received: September 22, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for the symptomatic treatment of fever and pain in mild to moderate. It comes in different formulations for oral, intravenous and rectal. The IV route allows rapid passage of paracetamol in the systemic arterial circulation and thus the brain, faster distribution evidenced a higher plasma concentration compared with oral and rectal. However the IV route also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy, unpleasant and painful.

The way per-Albus not to date used for the administration of paracetamol. It is a path nonetheless very interesting 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 a very rapid action. Furthermore, the terminal per-oral mucosa, less restrictive than IV administration and faster than oral administration, requires a simple medical gesture without special surveillance after administration, produces no pain or risk of infection for the patient (in contrast to the IV). It is interesting to test a new dosage form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and pharmacodynamics) with the only dosage form of reference used by the IV route.


Condition Intervention Phase
Healthy
Drug: Kinetics of plasma concentrations of paracetamol
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Kinetics of plasma concentrations of paracetamol [ Time Frame: after administration of paracetamol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in pain threshold testing mechanical stimulation (von Frey electronic). Follow-up to the pain assessed by VAS (visual analog rating) [ Time Frame: after administration of paracetamol ] [ Designated as safety issue: Yes ]
  • Variation of the amplitude of brain wave N2P2 induced thermal stimulus at the forearm (Evoked Potentials thermal) [ Time Frame: after administration of paracetamol ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Kinetics of plasma concentrations of paracetamol
    Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
    Drug: Placebo
    Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Detailed Description:

Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.

  Eligibility

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

Inclusion Criteria:

  • Healthy volunteers
  • Aged over 18 years and not more than 50 years
  • Males
  • Values of vital signs before administration of the test products:

    • NOT 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
  • Hypersensitivity to paracetamol
  • History of hepatitis B or C
  • Severe renal impairment
  • Hepatic insufficiency
  • 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 (aphthae)
  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: NCT00982215

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Unither Pharmaceuticals
Investigators
Principal Investigator: Gisèle Pickering University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00982215     History of Changes
Other Study ID Numbers: CHU-0057
Study First Received: September 22, 2009
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 26, 2014