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

Verified by: Arcion Therapeutics Inc, January 2010
First Received: June 10, 2008 | Last Updated: January 22, 2010 | Phase: Phase 2 | Start Date: May 2008
Overall Status: Completed | Estimated Enrollment: 170
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The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy...

Brief Summary

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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: December 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Arcion Therapeutics Inc Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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