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)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Diabetes
- Sponsor
- TheraVasc Inc.
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Reporting of Adverse Events During 12 Week Study Period
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
One placebo tablet administered twice daily for 12 weeks.
Intervention: Placebo
40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Intervention: Sodium nitrite
Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
Intervention: Placebo
80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Intervention: Sodium nitrite
Outcomes
Primary Outcomes
Reporting of Adverse Events During 12 Week Study Period
Time Frame: 12 weeks
The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sustained release sodium nitrite compared with placebo over a 12 week treatment period. The following safety parameters will also be assessed: concomitant medication usage, physical examination, vital signs, Comprehensive Metabolic Panel, and complete blood count. Assessment of acute adverse events (i.e., drop in blood pressure, dizziness) after administration of each dose level. Counts are number of subjects reporting at least 1 Adverse Event. The total Adverse Events recorded in each cohort is also reported.
Secondary Outcomes
- Pharmacokinetics (Blood Levels of Nitrite)(1 day)
- The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.(12 weeks)
- Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.(Baseline (visit 1) and 12 weeks (visit 3))
- Clinical Assessment of Pain. (Quantitative Sensory Testing)(12 weeks)
- Assessment of Diabetes. (HbA1C Levels)(12 weeks)
- Assessment of Blood Oxygenation. (Pulse Oximetry)(12 weeks)