NCT00628004已完成不适用
An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 10
- 主要终点
- Adverse events
研究概览
简要总结
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
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
- •The patient has participated in study DK143WS
- •The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
- •The patient is willing and able to give written informed consent
排除标准
- •Pregnant or lactating women
- •Concomitant participation in other studies
结局指标
主要结局
Adverse events
时间窗: Week 1, 6, 20, 33, 46
次要结局
- Clinical occurrences(Week 1, 6, 20, 33, 46)
- Ulcer area reduction(Week 1, 6, 20, 33, 46)
- Ulcer status(Week 1, 6, 20, 33, 46)
- Skin condition at healed ulcer location(Week 1, 6, 20, 33, 46)
研究者
研究点 (10)
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