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CompletedNCT00982215PMBUpdated Jan 30, 2012

Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa

A Phase 1 interventional study of Kinetics of plasma concentrations of paracetamol and Placebo in Healthy, sponsored by University Hospital, Clermont-Ferrand. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-30.

Sponsored by University Hospital, Clermont-Ferrand · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Healthy

Keywords

  • Paracetamol
  • per-oral mucosa PMB
  • No disease, healthy volunteers
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Interventions

  • DrugKinetics of plasma concentrations of paracetamol

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Kinetics of plasma concentrations of paracetamol

    Time frame: after administration of paracetamol

Secondary outcomes

  1. 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

  2. Variation of the amplitude of brain wave N2P2 induced thermal stimulus at the forearm (Evoked Potentials thermal)

    Time frame: after administration of paracetamol

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00982215
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Unither Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 23, 2009
Start date
Sep 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Jan 30, 2012

Study contacts

Gisèle Pickering
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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