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A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

Last updated on March 15, 2019

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Study Location
Clinical Research Consortium Arizona
Phoenix, Arizona, 85003 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
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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- Men and women aged 18 years to 80 years.

- Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c
(HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen
for at least 30 days prior to randomization.

- Presence of ongoing pain due to DPN for at least 6 months.

- Willing to discontinue protocol-specified prohibited pain medications for DPN
throughout the duration of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Painful neuropathies or painful conditions other than DPN that may confound evaluation
of pain due to DPN during the study.

- Subjects who have failed previously on pregabalin (at the recommended label dose and
for adequate duration) due to lack of efficacy.

- Subjects with any clinically significant medical or psychiatric conditions or
clinically significant laboratory test abnormalities.

- Pregnant women, lactating mothers, men with partners currently pregnant, women
suspected of being pregnant, and women who wish to be pregnant during the course of
the clinical study.

NCT02215252
Pfizer
Completed
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

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