Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Study Overview
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Brief Summary
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To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.

Official Title
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Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Conditions
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Diabetic Neuropathies

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: Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months. May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study. Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item. Exclusion Criteria: Glycosylated hemoglobin (A1C) > 12% Severe hepatic disease History of substance abuse or dependence within the past year, excluding nicotine and caffeine. Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study. Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study. Treatment of fluoxetine within 30 days of starting the study. Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) | Drug: Duloxetine Hydrochloride<br>* 60 mg every day (QD) (morning or evening), by mouth (PO)<br>* Other names: Cymbalta;|
| Placebo Comparator: Placebo<br>Placebo every day (QD), by mouth (PO) for 12 weeks | Drug: Placebo<br>* Placebo every day (QD), by mouth (PO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10). | Baseline and 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Baseline and 12 weeks | 
| Time Course of Change in Patient Global Impression - Improvement Scale | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | baseline, over 12 weeks | 
| Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. | Baseline and 12 weeks | 
| Number of Participants Discontinuing Due to Adverse Events |  | over 12 weeks | 
| Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events. | over 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15. | Baseline and 12 weeks | 
| Vital Signs - Weight | Change from baseline to endpoint in body weight. | Baseline and 12 weeks | 
| Vital Signs - Pulse Rate | Change from baseline to endpoint in pulse rate. | Baseline and 12 weeks | 
| Vital Signs - Blood Pressure | Change from baseline to endpoint in systolic and diastolic blood pressure. | Baseline and 12 weeks | 
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides. | Baseline and 12 weeks | 
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Significantly different laboratory values between the two groups in baseline to endpoint changes | Baseline and 12 weeks |