Status:
COMPLETED
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Lead Sponsor:
Arcion Therapeutics Inc
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00695565
Start Date
May 1 2008
End Date
February 1 2010
Last Update
November 8 2016
Active Locations (16)
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1
University of Alabama at Birmingham, School of Medicine
Birmingham, Alabama, United States, 35294
2
Northern California Research
Sacramento, California, United States, 95821
3
Neurological Research Institute
Santa Monica, California, United States, 90404
4
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401