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

Completed · Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy

In brief

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

Key facts

Study ID

NCT00695565

Run by

Arcion Therapeutics Inc

People needed

180

Starts

2008-05-01

Expected to finish

2010-02-01

Last updated by the study team

2016-11-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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