NCT02065349已完成2 期
A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 17
- 主要终点
- Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
研究概览
简要总结
The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.
详细描述
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PDPN subject must have:
- •Established diagnosis of diabetes (type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HbA1c) ≤ 11% at Screening.
- •Stable glycemic control (HbA1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to Screening.
- •At least a 1-year history of DPN pain.
- •Diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to Screening based on PI judgment and subject-reported medical history.
- •PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.
排除标准
- •Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
- •Previous investigational therapy within 28 days or 5 half lives
研究组 & 干预措施
Placebo
Placebo Comparator
oral
干预措施: Placebo (Drug)
ASP8477
Active Comparator
oral
干预措施: ASP8477 (Drug)
结局指标
主要结局
Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
时间窗: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period
次要结局
- Responder rate to ASP8477 in the Single-Blind Period(Baseline of the single-blind period (last 3 days of the placebo run-in period) to baseline of the double-blind period (last 3 days of the single-blind period)
- Patient Global Impression of Change (PGIC) score(From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation))
- Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score(From Screening to End of Study Visit (13 weeks))
- Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6(Day 14)
- Time to treatment failure(Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure)
研究者
研究点 (17)
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