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Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain, Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients must have low back pain with a neuropathic pain component between 3 months
and 12 months duration prior to entering the study.

- Patients must have a score of at least 19 on the PainDetect questionnaire and at least
4 on the Standardized Evaluation of Pain (StEP) scale at screening.

- Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during
the one week screening period.

- Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal
anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g.
tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering
the study).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of >
15 on the depression sub-scale only.

- Patients with a history of renal impairment or who have reduced renal function at
baseline (Creatinine Clearance

- Patients who have previously taken pregabalin or gabapentin within 6 months prior to
entering the study.

- Patients who have undergone previous surgery for back pain.

- Patients who are using high doses of opioid medication (morphine > 60 mg per day).

NCT01298466
Pfizer
Withdrawn
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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