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

Quigley Pharma

Status and phase

Completed

Phase 2

Conditions

Diabetic Neuropathy

Treatments

Drug: QR-333

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568035

QR-333-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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