Tramadol and Pain Sensitization

NCT ID: NCT00487175

Last Updated: 2009-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.

Detailed Description

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The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Tramadol

to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men
* Between 18 and 40 years old
* Written consent given

Exclusion Criteria

* Concomitant medication
* Tramadol hypersensibility
* Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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PICKERING Gisèle, MCU-PH, pharmacology

Role: PRINCIPAL_INVESTIGATOR

Locations

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CIC

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU63-0020

Identifier Type: -

Identifier Source: org_study_id

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