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Tramadol and Pain Sensitization

Information source: University Hospital, Clermont-Ferrand
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Tramadol (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University Hospital, Clermont-Ferrand

Official(s) and/or principal investigator(s):
PICKERING Gisèle, MCU-PH, pharmacology, Principal Investigator, Affiliation: unaffiliated

Overall contact:
PICKERING Gisèle, Phone: +33 4 73 17 84 10, Email: gisele.pickering@u-clermont1.fr

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.

Clinical Details

Official title: Tramadol and Pain Sensitization

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

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

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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

Locations and Contacts

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

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

Starting date: September 2007
Ending date: December 2007
Last updated: September 15, 2008

Page last updated: February 12, 2009

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