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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nerve Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP),
including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted
at least 3 months following the traumatic event.

- Patients during the screening week must have completed ≥ 4 daily pain scores and have
an average daily pain score ≥ 4.

- Female patients of childbearing potential must have a negative urine pregnancy test at
Screening and be practicing an acceptable form of contraception.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with
trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb
pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or
patients with any other co-existing pain which cannot be differentiate from NeP of
peripheral origin.

- Patients who have previously failed to respond to pregabalin at a total daily dose of
equal to or greater than 300 mg or are intolerant to those doses.

- Patients who have previously failed to respond to gabapentin at a total daily dose of
equal to or greater than 1800 mg.

- Patients with any type or history of malignancy, except either where there has been no
ongoing treatment for at least 6 months or all basal cell carcinomas; all patients
with a history of brain or spinal tumors will be excluded.

- Patients who currently have ongoing litigation related to any injury affecting their
pain symptomatology.

NCT00654940
Pfizer
Completed
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

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