Tramadol and Pain Sensitization - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Tramadol	Phase I

Drug Information available for:

Tramadol hydrochloride Tramadol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Official Title:	Tramadol and Pain Sensitization

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487175

Contacts


Contact: PICKERING Gisèle	+33 4 73 17 84 10	gisele.pickering@u-clermont1.fr

Locations


France
	CIC	Recruiting
	Clermont-Ferrand, France, 63000
	Contact: PICKERING Gisèle, MCU-PH, Pharmacology +33 4 73 17 84 10 gisele.pickering@u-clermont1.fr

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators


Principal Investigator:	PICKERING Gisèle, MCU-PH, pharmacology	unaffiliated

More Information

Responsible Party:	CHU Clermont-Ferrand ( Gisèle PICKERING )
Study ID Numbers:	CHU63-0020
First Received:	June 14, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00487175
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Pain

sensitization

analgesia

Healthy volunteers and pain

Study placed in the following topic categories:

Tramadol

Pain

Healthy

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00487175