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

Eli Lilly and Company1 site in 1 country215 target enrollmentDecember 2006

ConditionsDiabetic Neuropathies

InterventionsPlacebo Duloxetine Hydrochloride

DrugsDuloxetine Hydrochloride Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Enrollment: 215
Locations: 1
Primary Endpoint: Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

February 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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.

Arms & Interventions

Placebo

Placebo every day (QD), by mouth (PO) for 12 weeks

Intervention: Placebo

Duloxetine

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)

Intervention: Duloxetine Hydrochloride

Outcomes

Primary Outcomes

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score

Time Frame: Baseline and 12 weeks

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).

Secondary Outcomes

Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity(Baseline and 12 weeks)
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)(over 12 weeks)
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores(Baseline and 12 weeks)
Number of Participants Discontinuing Due to Adverse Events(over 12 weeks)
Time Course of Change in Patient Global Impression - Improvement Scale(baseline, over 12 weeks)
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)(Baseline and 12 weeks)
Vital Signs - Pulse Rate(Baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item(Baseline and 12 weeks)
Vital Signs - Weight(Baseline and 12 weeks)
Vital Signs - 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(Baseline and 12 weeks)
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid(Baseline and 12 weeks)