Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

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

Details

• Lead Sponsor: Arcion Therapeutics Inc
• Treatments: Clonidine

Criteria

Inclusion Criteria:

• has Type 1 or Type 2 diabetes mellitus

• has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria:

• has neuropathy secondary to non-diabetic causes

• has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN

• has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes

• is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain

• is pregnant or lactating