A Methodology Study of Brain Imaging of Pain-killers in Post-traumatic Neuropathic Pain Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

January 14, 2008

Last Updated Date

November 4, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Voxel-wise BOLD and ASL brain activation signals across the whole brain and in defined brain regions in response to painful (brush allodynia and heat) stimuli, ongoing pain and visual (checkerboard) stimuli [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Psychological assessment scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Neuropathic Pain Symptom Inventory score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Doleur neuropathic 4 "DN4" results [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Present Pain Intensity score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Daily Pain Score [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Methodology Study of Brain Imaging of Pain-killers in Post-traumatic Neuropathic Pain Patients

Official Title ^ICMJE

A Methodology Study to Assess the Feasibility of Using Functional Magnetic Resonance Imaging (fMRI) to Quantify the Effects of Analgesic Drugs in Post-traumatic Neuropathic Pain Subjects

Brief Summary

This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Placebo
Drug: Pregabalin
Drug: Tramadol SR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
Brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
Right-handed

Exclusion Criteria:

Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
Phantom limb pain, painful diabetic neuropathy.
Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
Subjects with diabetes mellitus and with an HbA1C value of >10% upon measurement at screening.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00610155

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0081173

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

University of Oxford

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP