Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
- Registration Number
- NCT00568035
- Lead Sponsor
- Quigley Pharma, Inc.
- Brief Summary
The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.
- Detailed Description
Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- diagnosis of diabetic neuropathy
- 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
- uncontrolled pain that has persisted for > 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QR-333 QR-333 - Placebo QR-333 -
- Primary Outcome Measures
Name Time Method Determine the safety of a three times daily application of QR-333 as compared to placebo. 12 Weeks
- Secondary Outcome Measures
Name Time Method Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo. 12 weeks
Trial Locations
- Locations (19)
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Rwjms/Umdnj
🇺🇸New Brunswick, New Jersey, United States
Hartwell Research Group / Anderson Family Care
🇺🇸Anderson, South Carolina, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
ECU Diabetes Research Center, Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Pacific Sleep Medicine Services, Inc
🇺🇸Fountain Valley, California, United States
Kaleida Health, Diabetes Center of WNY
🇺🇸Buffalo, New York, United States
Advanced Medical Research, LLC
🇺🇸Lakewood, California, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Rainier Clinical Research Center, Inc
🇺🇸Renton, Washington, United States
A&A Pain Institute
🇺🇸St. Louis, Missouri, United States
Stedman Clinical Trails
🇺🇸Tampa, Florida, United States
Land Clinical Studies
🇺🇸West Caldwell, New Jersey, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
dgd Research
🇺🇸San Antonio, Texas, United States
Seale Harris Clinic / Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Endeavor Clinical Trials, PA
🇺🇸San Antonio, Texas, United States
Baptist Clinical Research
🇺🇸Pensacola, Florida, United States