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

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NCT00610155

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Portsmouth, Hampshire, PO3 6AD United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00610155
Pfizer
Completed
A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients

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A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Placebo
    BID
  • Drug: Pregabalin
    Dose 75 mg titrated to 150 mg, bid
  • Drug: Tramadol SR
    Dose 50mg titrated to 200 mg, bid
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Pregabalin
  • Experimental: 3
    Intervention: Drug: Tramadol SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2010
July 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00610155
A0081173
No
Not Provided
Not Provided
Pfizer
Pfizer
University of Oxford
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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