NCT02156336终止4 期
A Double-Blind, Placebo-Controlled, Randomized, Parallel Assignment, U.S. Study of Ranolazine for the Treatment of Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Horizons International Peripheral Group2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2014年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
研究概览
简要总结
The purpose of this trial is to determine if patients suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo.
Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical animal model of neuropathic pain, the investigators hypothesize that subjects randomized to ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.
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
- •A minimum of 18 years of age;
- •Provided signed Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) authorization for this study approved by the Institutional Review Board;
- •Patients must have diabetic peripheral neuropathic pain rated at an average level of six (6) or above as documented in daily diary prior to baseline visit and noted at Baseline Visit;
- •Diabetic on a stable insulin regimen or oral medication regimen as determined by the investigator [It is recommended Hba1c < 9.5%, making a note that lab normal values may vary among sites.];
- •Clinical Exam Results:
- •5.07 Semmes-Weinstein Monofilament Test Subject does not sense monofilament or evokes an abnormal response in a minimum of two (2) out of five (5) test locations on the plantar surface of the foot.
- •Pin Prick Test Subject experiences allodynia, hyperalgesia, or sensory loss in two (2) out of five (5) test locations in the plantar surface - four (4) and dorsum - one (1) of the foot.
- •Willing and able to comply with the requirements of the protocol and follow directions from the clinic and research staff;
- •For female patients only:
- •Be post-menopausal (no menses for at least 2 years) or sterilized,
- •If subject of childbearing potential, not breastfeeding, has a negative pregnancy test at Baseline (pre-randomization, Day 0), has no intention of becoming pregnant during the course of the study, and is using one or more of the following contraceptive measures:
- •Stable regimen of hormonal contraception
- •Intra-uterine device
- •Condoms with spermicide
- •Diaphragm with spermicide
排除标准
- •History of allergy or intolerance to ranolazine;
- •Any condition or concomitant medication that would preclude the safe use of ranolazine as outlined in the prescribing information sheet;
- •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 participation in another experimental or investigational drug or device trial;
- •Pregnant or breast feeding;
- •Cirrhosis of the liver;
- •Psychological or addictive disorders (not limited to, but including for example, drug and/or alcohol dependency) that may preclude patient consent or compliance, or that may confound study interpretation;
- •Taking a moderate or strong CYP3A inhibitor (e.g. diltiazem, verapamil, ketoconazole, itraconazole, clarithromycin, erythromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir);
- •Taking inducers of Cytochrome P450, family 3, subfamily A (CYP3A) (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort);
- •Renal impairment as defined by a calculated serum creatinine clearance of < 30ml/min;
- •Lower back disorders where symptoms present similarly to DPNP;
- •Family history of long QT syndrome;
- •Congenital long QT syndrome;
- •Subjects taking tricyclic antidepressants;
- •Subjects taking anti-psychotic drugs;
- •Patient is taking > 850mg metformin BID;
- •Any subjects currently taking pregabalin;
- •Any subjects currently taking gabapentin;
- •Any subject currently taking Metanx®;
- •Any subjects currently taking continuous long-term narcotics;
- •Grapefruit and grapefruit containing products;
- •Use of P-gp inhibitors - cyclosporine.
研究组 & 干预措施
PLACEBO
Placebo Comparator
- 500 mg PLACEBO PO 2 times a day for 1 week (Week 1)
- 1000 mg PLACEBO PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6)
干预措施: Placebo (Drug)
RANOLAZINE
Active Comparator
- 500 mg RANOLAZINE PO 2 times a day for 1 week (Week 1)
- 1000 mg RANOLAZINE PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6)
干预措施: Ranolazine (Drug)
结局指标
主要结局
Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
时间窗: 6 weeks (42 Days)
次要结局
- Change in pain assessment measured by the Visual Analog Scale(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
- Change in pain assessment measured by Short-Form McGill Pain Questionnaire(Randomization (Day 0) and Day 42)
- Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
- Additional pain medication(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
- Occurrence of Adverse Events after randomization(56 Days)
- Change in Quality of Life Assessment as measured by SF-36 v2(Randomization (Day 0) and Day 42)
- Occurrence of Serious Adverse Events after randomization(56 Days)
研究者
研究点 (2)
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