Tramadol and Pain Sensitization

Pain Clinical Trial

— TRAMADOL  

Official title:

Tramadol and Pain Sensitization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487175
• Other study ID #: CHU63-0020
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2007
• Last updated: March 16, 2009
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2009
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tramadol
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials

Locations

Country	Name	City	State
France	CIC	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area		with an induced hyperalgic area	Yes