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

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathies

Treatments: Drug: Placebo; Drug: Duloxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408993

10599

F1J-MC-HMEQ(a) (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

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)

Treatment:

Drug: Duloxetine Hydrochloride

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo