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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Reporting of Adverse Events During 12 Week Study Period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
One placebo tablet administered twice daily for 12 weeks.
干预措施: Placebo (Drug)
40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
干预措施: Sodium nitrite (Drug)
Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
干预措施: Placebo (Drug)
80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
干预措施: Sodium nitrite (Drug)
结局指标
主要结局
Reporting of Adverse Events During 12 Week Study Period
时间窗: 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.
次要结局
- 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)