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 |
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)
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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