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NCT02412852 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
A Phase 2 study of Diabetes, sponsored by TheraVasc.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02412852 is a Phase 2 study of Diabetes that has completed, run by TheraVasc. The registered enrollment target is 26 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02412852, a Phase 2 study of Diabetes, has completed, sponsored by TheraVasc.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Sodium nitrite
Study Locations (1)
Ohio
- Ohio Pain Clinic - Centerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-04-28 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02412852
The ClinicalTrials.gov registry entry for NCT02412852 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is TheraVasc, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02412852 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02412852 about?
NCT02412852 is a clinical study titled "A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain". 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 tre...
What is the current status of trial NCT02412852?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2015-04-28. Estimated completion is 2017-04-03.
What conditions does trial NCT02412852 study?
This clinical trial studies the following conditions: Diabetes.
What interventions are being tested in trial NCT02412852?
The interventions under investigation include: Placebo (DRUG), Sodium nitrite (DRUG).
Who is sponsoring clinical trial NCT02412852?
This trial is sponsored by TheraVasc, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02412852 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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