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

Phase 3CompletedNCT00408993

Eli Lilly and Company215 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

215

Conditions

Diabetic Neuropathies

Interventions

Duloxetine HydrochlorideDRUG

60 mg every day (QD) (morning or evening), by mouth (PO)

PlaceboDRUG

Placebo every day (QD), by mouth (PO)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, China

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 12 weeks

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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Harbin, China

Nanjin, China

Nanjing, China

Shanghai, China

Wuhan, China

Time frame: Baseline and 12 weeks

Number of Participants Discontinuing Due to Adverse Events

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 12 weeks

Vital Signs - Weight

Change from baseline to endpoint in body weight.

Time frame: Baseline and 12 weeks

Vital Signs - Pulse Rate

Change from baseline to endpoint in pulse rate.

Time frame: Baseline and 12 weeks

Vital Signs - Blood Pressure

Change from baseline to endpoint in systolic and diastolic blood pressure.

Time frame: 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.

Time frame: 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

Time frame: Baseline and 12 weeks