A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reduction in Neuropathic Pain
研究概览
简要总结
This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.
Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Males or females aged ≥ 18 years
- •Coronary artery disease with a clinically diagnosed peripheral neuropathy
- •Willing and able to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
排除标准
- •History of allergy or intolerance to ranolazine
- •Any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see Appendix E)
- •In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
- •In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
- •Use of any experimental or investigational drug or device within 30 days prior to screening
- •Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in Inclusion Criterion 4)
- •Had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization
- •Clinically significant hepatic impairment
- •Had end-stage renal disease requiring dialysis
- •Psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
- •Positive pregnancy test at Baseline (pre-randomization, Day 0)
研究组 & 干预措施
Placebo-Ranolazine
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
干预措施: Ranolazine (Drug)
Placebo-Ranolazine
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
干预措施: Placebo (Drug)
Ranolazine-Placebo
Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
干预措施: Ranolazine (Drug)
Ranolazine-Placebo
Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in Neuropathic Pain
时间窗: Baseline to Week 6
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
次要结局
- Response to Thermal and Mechanical Stimuli(Baseline to Week 6)
- Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire(Baseline to Week 6)