Overview

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