Overview

This trial is active, not recruiting.

Condition diabetes
Treatments sodium nitrite, placebo
Phase phase 2
Sponsor TheraVasc Inc.
Collaborator Kettering Health Network
Start date May 2015
End date December 2015
Trial size 30 participants
Trial identifier NCT02412852, TheraVasc-TV1001-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
One placebo tablet administered twice daily for 12 weeks.
placebo
Placebo tablets
(Active Comparator)
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
sodium nitrite TV1001sr
Sustained release formulation of sodium nitrite
(Placebo Comparator)
Two placebo tablets administered twice daily for 12 weeks.
placebo
Placebo tablets
(Active Comparator)
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
sodium nitrite TV1001sr
Sustained release formulation of sodium nitrite

Primary Outcomes

Measure
Reporting of Adverse Events during 12 Week Study Period
time frame: 12 weeks

Secondary Outcomes

Measure
Pharmacokinetics (Blood levels of nitrite)
time frame: 1 day
Assessment in patients use of analgesic or medications for neuropathic pain.
time frame: 12 weeks
Assessment of patients reported pain through composite analysis of pain questionaires.
time frame: 12 weeks
Clinical assessment of pain. (Quantitative sensory testing)
time frame: 12 weels
Assessment of diabetes. (HbA1C levels)
time frame: 12 weeks
Assessment of blood oxygenation. (Pulse oximetry)
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Female subjects must be post-menopausal, sterilized or using suitable birth control - 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: - Patients with fibromyalgia or regional pain caused by lumbar or cervical compression - 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

Additional Information

Official title 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)
Principal investigator Amol Soin, PhD
Description This is a dose-ranging study to evaluate the safety, pharmacokinetics, and tolerability of multiple doses of an oral, sustained release formulation of sodium nitrite (TV1001sr) in subjects with DNP. The primary objective is to assess the safety and tolerability of multiple doses of twice daily 40 mg and 80 mg TV1001sr compared with placebo over a 12 week treatment period and the pharmacokinetics of the sustained release formulation of sodium nitrite. Secondary objectives are to evaluate the pharmacokinetics and markers of functional improvement including pain questionnaires, quantitative sensory testing and changes in markers of diabetes.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by TheraVasc Inc..