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| Descriptive Information Fields | |||||
| Brief Title † | Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy | ||||
| Official Title † | Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | 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 ] | ||||
| Condition † | Diabetic Neuropathy | ||||
| Intervention † | Drug: QR-333 | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 140 | ||||
| Start Date † | December 2006 | ||||
| Completion Date | November 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00568035 | ||||
| Organization ID | QR-333-002 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Quigley Pharma, Inc. | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Quigley Pharma, Inc. | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | December 3, 2007 | ||||
| Last Updated Date | August 5, 2008 | ||||