A Methodology Study of Brain Imaging of Pain-Killers in Post-Traumatic Neuropathic Pain Patients

Condition(s) targeted: Pain

Intervention: Placebo (Drug); Pregabalin (Drug); Tramadol SR (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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

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

Primary outcome: 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

Secondary outcome:

Psychological assessment scores

Neuropathic Pain Symptom Inventory score

Doleur neuropathic 4 "DN4" results

Present Pain Intensity score

Daily Pain Score

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of post-traumatic peripheral NeP syndrome, including post-surgical NeP.

- Presence of dynamic mechanical allodynia (brush allodynia) in the dermatomes

associated with specific dermatomes.

- Brush allodynia score of ≥4 and calculated average pain score of ≥4 on an 11-point

numerical rating scale by the completion of down-titration of existing medications.

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Exclusion Criteria:

- Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions,

multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).

- Complex region pain syndromes, phantom limb pain, radiculopathy, painful diabetic

neuropathy or post- Herpetic neuralgia.

- 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Portsmouth, Hampshire PO3 6AD, United Kingdom; Recruiting

Pfizer Investigational Site, Solihull, West Midlands B91 2JL, United Kingdom; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: September 2008
Ending date: July 2009
Last updated: October 13, 2008