Trial Information

Do you have diabetes? Do you suffer from persistent burning, throbbing, or tingling pain in your feet? Are you currently taking medication for this pain? We are seeking individuals with painful peripheral (feet/legs) diabetic neuropathy, who are taking NSAID's for pain conditions.

A phase 3B study of pregabalin in the treatment of subjects with painful diabetic peripheral neuropathy with background treatment of NSAID for other pain conditions. This study is 15-18 weeks in length, with 10 clinic visits. Pregabalin (lyrica) has been approved by the United States Food and Drug Administration for the treatment of neuropathic (nerve) pain associated with diabetic peripheral neuropathy. The purpose of this research study is to assess the effectiveness of pregabalin (lyrica) compared with placebo in subjects with painful diabetic peripheral neuropathy who use pain medication for the treatment of conditions other than diabetic peripheral neuropathy pain.

Patient Inclusion Criteria:

18 years of age and older
diagnosis of type 1 or 2 diabetes
on a anti-diabetic treatment regimen
diagnosis of painful peripheral (feet/legs) neuropathy
current treatment with one NSAID for a co-morbid pain condition

Patient Exclusion Criteria:

have taken pregabilin (lyrica) previously, and discontinued due to intolerance, or lack of efficacy
any amputations of lower extremities
cancer (other then basal cell or carcinoma) within the past 5 years

Julie K. Anderson, Site Director
Sunstone Medical Research, LLC
1904 E. Barnett Road
Medford, OR 97504
Phone: 541-973-2080
Fax: 541-973-2096
Email: research@sunstoneresearch.com

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Research Center Information: Sunstone Medical Research, LLC

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