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
• Trial end date: 2015-09-28
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Pregabalin

Criteria

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.