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A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain

NCT02412852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-04-24

Study results available
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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.

Conditions

Interventions

DRUG

Sodium nitrite

Sustained release formulation of sodium nitrite

DRUG

Placebo

Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.

Sponsors & Collaborators

  • Kettering Health Network

    collaborator OTHER

  • TheraVasc Inc.

    lead INDUSTRY

Principal Investigators

  • Amol Soin, PhD · Ohio Pain Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2015-12-07
Completion
2017-04-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412852 on ClinicalTrials.gov