At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
Sodium nitrite +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blinded, Phase 2a Study to Assess the Safety and Pharmacokinetics of a Sustained Release Formulation of Sodium Nitrite (TV1001sr) in Patients With Diabetic Neuropathic Pain (DNP)
In Brief
A Phase 2 clinical trial evaluating Sodium nitrite and Placebo for Diabetes. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
CollaboratorsKettering Health Network
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartApr 2015
Primary CompletionDec 2015
Study CompletionApr 2017
TodayJul 2026
First PostedApr 9, 2015
Enrollment StartApr 28, 2015
Primary CompletionDec 7, 2015
Study CompletionApr 3, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.2 years ago
Interventions
Sodium nitritedrug
Sustained release formulation of sodium nitrite
Placebodrug
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.