drugset / Trial / NCT02412852
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily. Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications affects on pain following treatment will also be recorded.
Timeline
- Start
- 2015-04-28
- Primary completion
- 2015-12-07
- Completion
- 2017-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Nitrite | Small molecule | 40 mg | Oral |
| Comparator | Sodium Nitrite | Small molecule | 80 mg | Oral |