Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
NCT ID: NCT00695565
Last Updated: 2016-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2008-05-31
2010-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Gel
Placebo Gel is vehicle without clonidine
Placebo Gel
TID x 12 weeks
Clonidine Topical Gel (ARC-4558)
Clonidine Topical Gel contains 0.1% clonidine hydrochloride
Clonidine Topical Gel (ARC-4558)
TID x 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo Gel
TID x 12 weeks
Clonidine Topical Gel (ARC-4558)
TID x 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arcion Therapeutics Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James N Campbell, M.D.
Role: STUDY_CHAIR
Arcion Therapeutics Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Campbell CM, Kipnes MS, Stouch BC, Brady KL, Kelly M, Schmidt WK, Petersen KL, Rowbotham MC, Campbell JN. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy. Pain. 2012 Sep;153(9):1815-1823. doi: 10.1016/j.pain.2012.04.014. Epub 2012 Jun 8.
Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLO-027
Identifier Type: -
Identifier Source: org_study_id