An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride; Gabapentin; gamma-Aminobutyric Acid; Pregabalin

Criteria

Inclusion Criteria:

• You must have been diagnosed with Diabetic Neuropathic Pain

• Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted

• Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report

• Patient must agree not to change dose of gabapentin between Visits 1 and 2

• You must have stable glycemic control

Exclusion Criteria:

• Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)

• Current diagnosis or history of hemangiosarcoma

• Patients with New York Heart Association Class III or IV symptoms of congestive heart failure

• Patients with uncontrolled narrow-angle glaucoma

• Presence of a current seizure disorder