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)



Status:Completed
Conditions:Diabetic Neuropathy, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:November 2014
End Date:September 2015

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A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate Pf-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a
monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral
neuropathy (DPN)


Inclusion Criteria:

- 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:

- 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.
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Evansville, Indiana 47714
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Evansville, IN
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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Norfolk, Virginia 23507
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Ann Arbor, MI
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Bradenton, Florida
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Brandon, Florida 33511
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Brandon, Florida 33511
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Brooksville, Florida
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Columbus, Georgia 31904
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Dallas, Texas 75230
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Hallandale, Florida 33009
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Houston, Texas 77030
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Knoxville, Tennessee 37923
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Lakeland, Florida 33805
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Las Vegas, Nevada 89119
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New Bedford, Massachusetts 02740
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New York, New York 10128
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Ocala, Florida 34471
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Oviedo, Florida 32765
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Phoenix, Arizona 85023
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Quincy, Massachusetts 02169
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Renton, Washington 98057
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St. Petersburg, Florida
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Tampa, Florida
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Tullahoma, Tennessee 37388
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Tullahoma, Tennessee 37388
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West Palm Beach, Florida
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