Tramadol and Pain Sensitization | NCT00487175

Studies
Tramadol and Pain Sensitization

NCT00487175

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Mar 17, 2009Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Pain

Interventions

Tramadol

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Jun 14, 2007

First Submission Date that Met QC Criteria

Jun 14, 2007

First Posted Date

Jun 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2009

Last Update Posted Date

Mar 17, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tramadol	Drug	to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PICKERING Gisèle, MCU-PH, pharmacology		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CIC		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014147	Tramadol

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided