Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathies

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322621

10258

F1J-MC-HMEM (Other Identifier)

Details and patient eligibility

About

To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Enrollment: 216 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

• 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, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be 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 with fluoxetine within 30 days of starting the study.
• Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 1 patient group

Duloxetine

Experimental group

Description:

All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.

Treatment:

Drug: Duloxetine