A Study for the Treatment of Painful Diabetic Neuropathy

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Male or female outpatients at least 18 years of age.

• Patients with pain due to diabetic neuropathy in both legs.

• Females must not be pregnant or plan to become pregnant during the study.

• Stable Glycemic control.

• Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.

Exclusion Criteria:

• You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.

• You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.

• You have participated in a study for an investigational drug within the last 30 days.

• You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.

• You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.