A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
NCT ID: NCT02412852
Last Updated: 2020-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2015-04-28
2017-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
One placebo tablet administered twice daily for 12 weeks.
Placebo
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite
Sustained release formulation of sodium nitrite
Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
Placebo
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite
Sustained release formulation of sodium nitrite
Interventions
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Sodium nitrite
Sustained release formulation of sodium nitrite
Placebo
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes (HbA1c \> 6.0)
* Diagnosis of diabetic peripheral neuropathy pain in feet
* Presence of ongoing diabetic neuropathic for at least 3 months
* A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
* Ability to provide written informed consent
Exclusion Criteria
* History or diagnosis of significant neurological disease
* History and diagnosis of clinically significant psychiatric diseases
* Serious liver disease
* Poorly controlled diabetes
* Hypersensitivity to sodium nitrite or related compounds
* Life expectancy \< 6 months
* A chronic illness that may increase the risks associated with this study
* Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
* Pregnant or nursing women
* Current diagnosis of alcohol or other substance abuse
* Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
* History of methemoglobinemia, (met-Hb ≥ 15%)
* Subject is involved in litigation or receives worker's compensation
* Inability to speak English
18 Years
ALL
No
Sponsors
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Kettering Health Network
OTHER
TheraVasc Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amol Soin, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio Pain Clinic
Locations
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Ohio Pain Clinic
Centerville, Ohio, United States
Countries
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Other Identifiers
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TheraVasc-TV1001-003
Identifier Type: -
Identifier Source: org_study_id
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