A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

• Status: Completed
• Trial end date: 2009-03-01
• 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
• Collaborator: Shionogi
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.

• Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit 1.

• Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit 1.

• Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2

Exclusion Criteria:

• Participants who have undergone renal transplant or who are currently on renal dialysis.

• Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.

• Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg

• Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit 1.

• Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.