Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.

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

Details

• Lead Sponsor: Swedish Orphan Biovitrum

Criteria

Inclusion Criteria:

• A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months

• Either no analgesic medication or on stable analgesic medication for at least 4 weeks

Exclusion Criteria:

• Female patients who are fertile and of child-bearing potential

• Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease

• Painful conditions that may confound the evaluation of neuropathic pain