A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.

Detailed Description
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Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Conditions
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Pain, Diabetic Neuropathies

Intervention / Treatment
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* Drug: V3381
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18-75 years of age Diabetes mellitus (type I or type II) No change in medications for reducing blood sugar within 4 weeks before screening Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years Neuropathic pain must begin in the feet, with relatively symmetrical onset. Willing to perform self-monitoring of blood glucose Able to communicate intelligibly with the investigator and study coordinator Keeping all appointments for clinic visits, tests, and procedures Exclusion Criteria: Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain) Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study Prior renal transplant or current renal dialysis Pernicious anemia Untreated hypothyroidism Amputations due to diabetes mellitus (with the exception of toes) Any clinically significant abnormal electrocardiogram (ECG) Any history of cardiac arrhythmia History of myocardial infarction Active angina Uncontrolled hypertension (i.e., > 140/90 mm Hg) Known or at high risk of hepatitis B or C infection Known or at high risk of human immunodeficiency virus (HIV) infection Any anticipated need for surgery during the study Glycosylated hemoglobin (HbA1c) > 9% Known seizure disorder Any malignancy in the past 2 years (with the exception of basal cell carcinoma) Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain. Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents History of substance abuse or dependence within the past year, excluding nicotine and caffeine Frequent and/or severe allergic reactions with multiple medications Participation in any clinical trial within 30 days before screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: V3381|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11 point numerical pain rating scale (NPRS) daily diary |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Brief Pain Inventory for DPN |  |  | 
| McGill Pain Questionnaire - Short Form |  |  | 
| Neuropathic Pain Symptom Inventory |  |  | 
| Medical Outcomes Survey Short Form - 12, Version 2 |  |  | 
| Patient Global Impression of Change |  |  | 
| Patient Preference Questionnaire (end of 2nd treatment period only) |  |  | 
| Clinical Global Impression of Change |  |  | 
| Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics |  |  | 
| daily sleep interference score |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain associated with diabetes Type I or Type II, Neuropathic Pain due to diabetes, Diabetic peripheral neuropathic pain, Pain, Diabetes with burning sensation in the arms and/or legs, Diabetes with tingling sensation in the arms and/or legs, Neuropathic Pain Due to Diabetes Type I or Type II