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.
We found this trial at
32
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Brandon, Florida 33511
2535
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Brandon, FL
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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
758
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Fresno, CA
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Norfolk, Virginia 23507
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Norfolk, VA
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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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Brooksville, Florida
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Brooksville, FL
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Columbus, Georgia 31904
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Dallas, Texas 75230
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Evansville, Indiana 47714
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Evansville, IN
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Hallandale, Florida 33009
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Houston, Texas 77030
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Houston, TX
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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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Norfolk, VA
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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
12
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St. Petersburg, Florida
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Tampa, Florida
2527
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Tampa, FL
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Tullahoma, Tennessee 37388
2029
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Tullahoma, Tennessee 37388
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West Palm Beach, Florida
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West Palm Beach, FL
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