A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
Status:
Completed
Trial end date:
2017-04-03
Target enrollment:
Participant gender:
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.