Status:
COMPLETED
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00385671
Start Date
September 1 2006
End Date
November 1 2009
Last Update
July 26 2011
Active Locations (9)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Torrance, California, United States, 90503
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cromwell, Connecticut, United States, 06416
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Staten Island, New York, United States, 10312
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenville, North Carolina, United States, 27834