drugset / Trial / NCT01089556
A Study in Painful Diabetic Neuropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | Oral |
| Subject | Duloxetine | Small molecule | 120 mg | Oral |
| Subject | Pregabalin | Small molecule | 300 mg | Oral |
| Subject | Pregabalin | Small molecule | 600 mg | Oral |