Tramadol and Pain Sensitization
TRAMADOL
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pain
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedMarch 17, 2009
March 1, 2009
3 months
June 14, 2007
March 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
with an induced hyperalgic area
Interventions
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Eligibility Criteria
You may qualify if:
- Healthy men
- Between 18 and 40 years old
- Written consent given
You may not qualify if:
- Concomitant medication
- Tramadol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CIC
Clermont-Ferrand, 63000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PICKERING Gisèle, MCU-PH, pharmacology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
September 1, 2007
Primary Completion
December 1, 2007
Study Completion
March 1, 2008
Last Updated
March 17, 2009
Record last verified: 2009-03