NCT01757873已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Z160 in Subjects With Postherpetic Neuralgia
Zalicus1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
研究概览
简要总结
This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
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
- •Provide written informed consent.
- •Either sex but must be aged >=18 years.
- •Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster >=6 months after the herpes zoster skin rash has healed.
- •Pain score over the last week of >=3 and <=8 on the PI-NRS
- •If female, the subject must be postmenopausal , surgically sterilized for >=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
- •Willing and able to comply with all study procedures.
排除标准
- •Severe pain caused by diseases other than PHN.
- •Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
- •History of seizure, excluding pediatric febrile seizures, or currently has seizures.
- •Stroke or transient ischemic attack (TIA) <=6 months before the screening visit.
- •History of or a current diagnosis of schizophrenia or bipolar disorder.
- •Major depressive disorder or generalized anxiety disorder <=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study.
- •Clinically significant alcohol or substance dependency <=1 year before the screening visit
- •Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit.
- •Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety.
- •Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed >1 year before screening and has not recurred).
- •Condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Illness within 30 days before screening.
- •History of hypersensitivity to calcium channel blockers.
- •Multiple drug allergies
- •Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose capsaicin patch (Qutenza) <=30 days before the screening visit.
- •Moderate or strong cytochrome P450 inducer within 30 days before the screening visit.
- •Digoxin or prohibited medications that cannot be discontinued before randomization.
- •Other exclusions apply.
研究组 & 干预措施
Z160
Experimental
375 mg BID
干预措施: Z160 (Drug)
Placebo
Placebo Comparator
matching placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
时间窗: Baseline to Week 6
次要结局
- Neuropathic Pain Scale (NPS)(Baseline to Weeks 1, 2, 4, 6)
- Short Form 36 (SF-36)(Baseline to Week 6)
- Z160 plasma concentrations(Baseline to Weeks 1, 2, 4, 6)
- Time to a >= 50% reduction in weekly average pain score(Baseline to Weeks 1, 2, 3, 4, 5, 6)
- Subjects who have >= 30% reduction in average daily pain score(Baseline to Week 6)
- Change from baseline in weekly average pain score(Baseline to Weeks 1, 2, 3, 4, 5, 6)
- Patient Global Impression of Change (PGIC)(Baseline to Week 6)
- Profile of Mood States (POMS)(Baseline to Weeks 1, 2, 4, 6)
- Daily Sleep Interference Scale (DSIS)(Baseline to Weeks 1, 2, 3, 4, 5, 6)
- Time to a >= 30% reduction in weekly average pain score(Baseline to Weeks 1, 2, 3, 4, 5, 6)
- Subjects who have >= 50% reduction in average daily pain score(Baseline to Week 6)
- Safety and tolerability(Baseline to Weeks 1- 12)
- Amount of rescue medication used(Baseline to Weeks 1, 2, 4 and 6)
研究者
研究点 (1)
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