Trial | NCT00568035  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    quercetin ...

  • Study Participants

    140
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.
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.
Study Started
Dec 31
2006
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
Jan 08
2009
Estimate

Drug QR-333

QR-333 or placebo will be applied three times a day for 12 weeks

QR-333 Active Comparator

Placebo Placebo Comparator

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.
No Results Posted