Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
This study has been completed.
Sponsor:
Quigley Pharma, Inc.
Information provided by:
Quigley Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00568035
First received: December 3, 2007
Last updated: January 7, 2009
Last verified: January 2009
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
Further study details as provided by Quigley Pharma, Inc.:
Primary Outcome Measures:
- Determine the safety of a three times daily application of QR-333 as compared to placebo. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Active Comparator: QR-333 |
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
|
| Placebo Comparator: Placebo |
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- uncontrolled pain that has persisted for > 12 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568035
Locations
| 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 | |
| Pacific Sleep Medicine Services, Inc | |
| Fountain Valley, California, United States, 92708 | |
| Advanced Medical Research, LLC | |
| Lakewood, California, United States, 90712 | |
| Diablo Clinical Research, Inc. | |
| Walnut Creek, California, United States, 94598 | |
| United States, Florida | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Baptist Clinical Research | |
| Pensacola, Florida, United States, 35201 | |
| Stedman Clinical Trails | |
| Tampa, Florida, United States, 33613 | |
| Metabolic Research Institute, Inc. | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Missouri | |
| A&A Pain Institute | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Rwjms/Umdnj | |
| New Brunswick, New Jersey, United States, 08903 | |
| Land Clinical Studies | |
| West Caldwell, New Jersey, United States, 07006 | |
| 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 | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| Endeavor Clinical Trials, PA | |
| San Antonio, Texas, United States, 78229 | |
| dgd Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Rainier Clinical Research Center, Inc | |
| Renton, Washington, United States, 98057 | |
Sponsors and Collaborators
Quigley Pharma, Inc.
Investigators
| Study Chair: | Philip Raskin, MD | University of Texas Southwestern Medical Center at Dallas |
More Information
No publications provided
| Responsible Party: | Quigley Pharma, Inc., Richard Rosenbloom |
| ClinicalTrials.gov Identifier: | NCT00568035 History of Changes |
| Other Study ID Numbers: | QR-333-002 |
| Study First Received: | December 3, 2007 |
| Last Updated: | January 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Quigley Pharma, Inc.:
|
diabetic peripheral neuropathy |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013