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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Drug: QR-333


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QR-333<br> | Drug: QR-333<br>* QR-333 or placebo will be applied three times a day for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: QR-333<br>* QR-333 or placebo will be applied three times a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety of a three times daily application of QR-333 as compared to placebo. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic, peripheral, neuropathy