Status:
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)
Lead Sponsor:
Pfizer
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2015
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT02215252
Start Date
November 10 2014
End Date
September 28 2015
Last Update
May 5 2017
Active Locations (32)
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1
Clinical Research Consortium Arizona
Phoenix, Arizona, United States, 85003
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Neuro-Pain Medical Center
Fresno, California, United States, 93710
4
Meridien Research
Bradenton, Florida, United States, 34208