Tramadol and Pain Sensitization (TRAMADOL)

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT00487175

First received: June 14, 2007

Last updated: March 16, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 14, 2007

Last Updated Date

March 16, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area [ Time Frame: with an induced hyperalgic area ]

Original Primary Outcome Measures ^ICMJE

Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area

Change History

Complete list of historical versions of study NCT00487175 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tramadol and Pain Sensitization

Official Title ^ICMJE

Tramadol and Pain Sensitization

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Tramadol

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00487175

Other Study ID Numbers ^ICMJE

CHU63-0020

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Gisèle PICKERING, CHU Clermont-Ferrand

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

PICKERING Gisèle, MCU-PH, pharmacology

PRS Account

University Hospital, Clermont-Ferrand

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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