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

NCT ID: NCT00610155

Last Updated: 2021-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BID

2

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Dose 75 mg titrated to 150 mg, bid

3

Group Type EXPERIMENTAL

Tramadol SR

Intervention Type DRUG

Dose 50mg titrated to 200 mg, bid

Interventions

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Placebo

BID

Intervention Type DRUG

Pregabalin

Dose 75 mg titrated to 150 mg, bid

Intervention Type DRUG

Tramadol SR

Dose 50mg titrated to 200 mg, bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Portsmouth, Hampshire, United Kingdom

Site Status

Pfizer Investigational Site

Solihull, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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A0081173

Identifier Type: -

Identifier Source: org_study_id

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