NCT01688947已完成2 期
A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
研究概览
简要总结
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
- •Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.
排除标准
- •Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- •Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
- •Subjects with a recent history of seizure within the past 5 years.
- •Subjects who use opioids more than 4 days per week.
- •Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
- •Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
- •PHN-pain-condition-specific exclusions:
- •Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.
- •Active-comparator-related exclusions:
- •Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.
- •Other protocol specific inclusion/exclusion criteria may apply.
研究组 & 干预措施
V116517 - 50 mg
Experimental
V116517 50-mg tablets
干预措施: V116517 50-mg tablets (Drug)
V116517 - 50 mg
Experimental
V116517 50-mg tablets
干预措施: Placebo (Drug)
V116517 - 30 mg
Experimental
V116517 30-mg tablets
干预措施: V116517 30-mg tablets (Drug)
V116517 - 30 mg
Experimental
V116517 30-mg tablets
干预措施: Placebo (Drug)
Pregabalin
Active Comparator
Pregabalin capsules
干预措施: Pregabalin capsules (Drug)
Pregabalin
Active Comparator
Pregabalin capsules
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
时间窗: Week 4
次要结局
- mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)(Week 4)
- Neuropathic Pain Symptom Inventory (NPSI)(Week 4)
- Patient Global Impression of Change (PGIC)(Week 4)
- Supplemental Analgesic Medication Use(Over 4 weeks)
研究者
研究点 (1)
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