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

Sponsors and Collaborators:	Pfizer University of Oxford
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00610155

Purpose

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.

Condition	Intervention
Pain	Drug: Placebo Drug: Pregabalin Drug: Tramadol SR

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacodynamics Study
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

Resource links provided by NLM:

Drug Information available for: Tramadol Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo BID
2: Experimental	Drug: Pregabalin Dose 75 mg titrated to 150 mg, bid
3: Experimental	Drug: Tramadol SR Dose 50mg titrated to 200 mg, bid

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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. 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).
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610155

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United Kingdom, Hampshire
Pfizer Investigational Site	Recruiting
Portsmouth, Hampshire, United Kingdom, PO3 6AD
United Kingdom, West Midlands
Pfizer Investigational Site	Recruiting
Solihull, West Midlands, United Kingdom, B91 2JL

Sponsors and Collaborators

Pfizer

University of Oxford

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081173
Study First Received:	January 14, 2008
Last Updated:	June 1, 2009
ClinicalTrials.gov Identifier:	NCT00610155 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Tramadol
Pregabalin
Pain

Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Pregabalin
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009