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Sponsored by: |
Quigley Pharma, Inc. |
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Information provided by: | Quigley Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00568035 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Neuropathy |
Drug: QR-333 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy |
Estimated Enrollment: | 140 |
Study Start Date: | December 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
QR-333: Active Comparator |
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
|
Placebo: Placebo Comparator |
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Parkway Medical Center | |
Birmingham, Alabama, United States, 35215 | |
Seale Harris Clinic / Alliance Clinical Research | |
Birmingham, Alabama, United States, 35216 | |
United States, California | |
Advanced Medical Research, LLC | |
Lakewood, California, United States, 90712 | |
Pacific Sleep Medicine Services, Inc | |
Fountain Valley, California, United States, 92708 | |
Diablo Clinical Research, Inc. | |
Walnut Creek, California, United States, 94598 | |
United States, Florida | |
Metabolic Research Institute, Inc. | |
West Palm Beach, Florida, United States, 33401 | |
Stedman Clinical Trails | |
Tampa, Florida, United States, 33613 | |
Renstar Medical Research | |
Ocala, Florida, United States, 34471 | |
Baptist Clinical Research | |
Pensacola, Florida, United States, 35201 | |
United States, Missouri | |
A&A Pain Institute | |
St. Louis, Missouri, United States, 63141 | |
United States, New Jersey | |
Land Clinical Studies | |
West Caldwell, New Jersey, United States, 07006 | |
RWJMS/UMDNJ | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
Kaleida Health, Diabetes Center of WNY | |
Buffalo, New York, United States, 14209 | |
United States, North Carolina | |
ECU Diabetes Research Center, Brody School of Medicine | |
Greenville, North Carolina, United States, 27834 | |
United States, South Carolina | |
Hartwell Research Group / Anderson Family Care | |
Anderson, South Carolina, United States, 29621 | |
United States, Texas | |
Endeavor Clinical Trials, PA | |
San Antonio, Texas, United States, 78229 | |
UT Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390 | |
dgd Research | |
San Antonio, Texas, United States, 78229 | |
United States, Washington | |
Rainier Clinical Research Center, Inc | |
Renton, Washington, United States, 98057 |
Study Chair: | Philip Raskin, MD | University of Texas Southwestern Medical Center at Dallas |
Responsible Party: | Richard Rosenbloom ( Quigley Pharma, Inc. ) |
Study ID Numbers: | QR-333-002 |
Study First Received: | December 3, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00568035 |
Health Authority: | United States: Food and Drug Administration |
diabetic peripheral neuropathy |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Diabetes Complications |
Nervous System Diseases |