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

Painful Diabetic Neuropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695565
• Other study ID #: CLO-027
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2008
• Last updated: January 22, 2010
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Arcion Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Painful Diabetic Neuropathy

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham, School of Medicine	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	Pain Treatment Center of the Bluegrass	Lexington	Kentucky
United States	Waccamaw Pain Partners/Crescent Moon Research	Murrells Inlet	South Carolina
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Strelitz Diabetes Institute, Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Northern California Research	Sacramento	California
United States	Diabetes and Glandular Disease Center	San Antonio	Texas
United States	Neurological Research Institute	Santa Monica	California
United States	Swedish Pain Center	Seattle	Washington
United States	Metabolic Research Institute	West Palm Beach	Florida
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Arcion Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change from Baseline in NPRS score		12 weeks	No
Secondary	mean change from Baseline in NPRS score at each week		weekly	No
Secondary	Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment		weekly	No