Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
NCT ID: NCT00568035
Last Updated: 2009-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2006-12-31
2008-11-30
Brief Summary
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Detailed Description
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To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).
The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QR-333
QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
Placebo
QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
Interventions
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QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
* must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Quigley Pharma, Inc.
INDUSTRY
Responsible Party
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Richard Rosenbloom
Principal Investigators
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Philip Raskin, MD
Role: STUDY_CHAIR
University of Texas, Southwestern Medical Center at Dallas
Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Seale Harris Clinic / Alliance Clinical Research
Birmingham, Alabama, United States
Pacific Sleep Medicine Services, Inc
Fountain Valley, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Renstar Medical Research
Ocala, Florida, United States
Baptist Clinical Research
Pensacola, Florida, United States
Stedman Clinical Trails
Tampa, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
A&A Pain Institute
St Louis, Missouri, United States
Rwjms/Umdnj
New Brunswick, New Jersey, United States
Land Clinical Studies
West Caldwell, New Jersey, United States
Kaleida Health, Diabetes Center of WNY
Buffalo, New York, United States
ECU Diabetes Research Center, Brody School of Medicine
Greenville, North Carolina, United States
Hartwell Research Group / Anderson Family Care
Anderson, South Carolina, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
dgd Research
San Antonio, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Rainier Clinical Research Center, Inc
Renton, Washington, United States
Countries
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Other Identifiers
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QR-333-002
Identifier Type: -
Identifier Source: org_study_id
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