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A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients

This study has been completed.
Sponsor:
Collaborator:
University of Oxford
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00610155
First received: January 14, 2008
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects

Resource links provided by NLM:

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 ]

Enrollment: 18
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
BID
Experimental: 2 Drug: Pregabalin
Dose 75 mg titrated to 150 mg, bid
Experimental: 3 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610155

Locations
United Kingdom
Pfizer Investigational Site
Portsmouth, Hampshire, United Kingdom, PO3 6AD
Pfizer Investigational Site
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: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00610155     History of Changes
Other Study ID Numbers: A0081173
Study First Received: January 14, 2008
Last Updated: November 30, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Tramadol
Pregabalin
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013