NCT00695565已完成2 期
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy
Arcion Therapeutics Inc16 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 16
- 主要终点
- Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation
研究概览
简要总结
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has Type 1 or Type 2 diabetes mellitus
- •has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening
排除标准
- •has neuropathy secondary to non-diabetic causes
- •has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN
- •has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes
- •is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain
- •is pregnant or lactating
研究组 & 干预措施
Placebo Gel
Placebo Comparator
Placebo Gel is vehicle without clonidine
干预措施: Placebo Gel (Drug)
Clonidine Topical Gel (ARC-4558)
Active Comparator
Clonidine Topical Gel contains 0.1% clonidine hydrochloride
干预措施: Clonidine Topical Gel (ARC-4558) (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation
时间窗: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)
Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain". The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief).
次要结局
- Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)(Baseline and Week 12)
- Patient Global Impression of Change (PGIC) at Week 12(Week 12)
- Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation(Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84))
- Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score(Baseline and Week 12)
- Change in Blood Pressure From Baseline to Week 12(Baseline and Week 12)
- Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation(Baseline and Week 12)
- Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)(Baseline and Week 12)
- Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation(Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84))
- Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation(Baseline and Week 12)
- Clinician Global Impression of Change (CGIC) at Week 12(Week 12)
- Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation(Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages))
- Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation(Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84))
- Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)(Baseline and Week 12)
研究者
研究点 (16)
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