A Study for the Treatment of Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Detailed Description
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The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.

Official Title
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Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Drug: Duloxetine hydrochloride
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients at least 18 years of age. Patients with pain due to diabetic neuropathy in both legs. Females must not be pregnant or plan to become pregnant during the study. Stable Glycemic control. Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary. Exclusion Criteria: You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company. You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis. You have participated in a study for an investigational drug within the last 30 days. You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders. You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine hydrochloride|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in average pain severity as measured by an 11-point Likert scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity for worst pain and night pain as measured by an 11-point Likert scale. |  |  | 
| Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment. |  |  | 
| Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. |  |  | 
| Brief Pain Inventory to measure the severity of pain. |  |  | 
| Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors. |  |  | 
| Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy. |  |  | 
| Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, pain, diabetes, chronic pain, persistent pain, leg pain, peripheral neuropathy, foot pain, painful neuropathy, diabetic neuropathy