Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Quigley Pharma, Inc.
- Enrollment
- 140
- Locations
- 19
- Primary Endpoint
- Determine the safety of a three times daily application of QR-333 as compared to placebo.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
QR-333
Intervention: QR-333 (Drug)
Placebo
Intervention: QR-333 (Drug)
Outcomes
Primary Outcomes
Determine the safety of a three times daily application of QR-333 as compared to placebo.
Time Frame: 12 Weeks
Secondary Outcomes
- 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.(12 weeks)