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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: placebo
  • TID x 12 weeks
• Drug: topical clonidine (ARC-4558)
  • TID x 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1. Placebo
• Active Comparator: 2. ARC-4558

Primary Measures

• mean change from Baseline in NPRS score
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• mean change from Baseline in NPRS score at each week
  • Time Frame: weekly
    Safety Issue?: No
• Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment
  • Time Frame: weekly
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Arcion Therapeutics Inc

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695565

Study ID Number: CLO-027

ClinicalTrials.gov Identifier: NCT00695565

Health Authority: United States: Food and Drug Administration