drugset / Trial / NCT00385671
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2009-08
- Completion
- 2009-11
Outcome
Met primary endpoint
paper The 97.5% lower confidence limit was a -0.05 difference in means, establishing noninferiority. PMID 21719618 ↗
Publications
- Results Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, Malcolm SK. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc. 2011 Jul;86(7):615-26. doi: 10.4065/mcp.2010.0681.
- Irving G, Tanenberg RJ, Raskin J, Risser RC, Malcolm S. Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. Int J Clin Pract. 2014 Sep;68(9):1130-40. doi: 10.1111/ijcp.12452. Epub 2014 May 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | Oral |
| Comparator | Pregabalin | Small molecule | 100 mg | Oral |
| Comparator | Pregabalin | Small molecule | 150 mg | Oral |
| Background | Gabapentin | Unknown | — | Oral |