NCT00385671

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

An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	duloxetine hydrochloride	Duloxetine (DLX) once daily (QD), orally (PO)
DRUG	pregabalin	Pregabalin (PGB) orally (PO)
DRUG	gabapentin	Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-08-01
• Completion: 2009-11-01
• First posted: 2006-10-11
• Last updated: 2011-07-26
• Results posted: 2010-10-18

Locations

9 sites across 2 countries: United States, Germany