Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 19
- 主要终点
- Determine the safety of a three times daily application of QR-333 as compared to placebo.
研究概览
简要总结
The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.
详细描述
Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.
To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).
The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of diabetic neuropathy
- •must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
- •must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed
排除标准
- •uncontrolled pain that has persisted for > 12 months.
研究组 & 干预措施
QR-333
干预措施: QR-333 (Drug)
Placebo
干预措施: QR-333 (Drug)
结局指标
主要结局
Determine the safety of a three times daily application of QR-333 as compared to placebo.
时间窗: 12 Weeks
次要结局
- Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo.(12 weeks)