drugset / Trial / NCT01496365
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Timeline
- Start
- 2011-11-28
- Primary completion
- 2012-09-07
- Completion
- 2012-09-07
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs DS-5565 15 mg BID; p = 0.0060; Least square means -1.01 (95% CI -1.74 to -0.29); ANCOVA NCT01496365 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirogabalin | Small molecule | 5 mg | — |
| Subject | Mirogabalin | Small molecule | 10 mg | — |
| Subject | Mirogabalin | Small molecule | 15 mg | — |
| Subject | Mirogabalin | Small molecule | 20 mg | — |
| Subject | Mirogabalin | Small molecule | 30 mg | — |
| Comparator | Pregabalin | Small molecule | 300 mg | — |