NCT00568035

Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy

Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Quigley Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	QR-333	QR-333 or placebo will be applied three times a day for 12 weeks

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-12-05
• Last updated: 2009-01-08

Locations

19 sites across 1 country: United States