NCT01541930已完成3 期
An Open, Uncontrolled Study Investigating the Safety and Efficacy of GK567 in the Deodorization of Malodorous Infected Cutaneous Fungating Neoplastic Tumours, Over 14 Days of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The Success Rate
研究概览
简要总结
This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment.
The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or female aged between 20 years or older.
- •The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)
排除标准
- •The subject is currently receiving systemic antibiotics or received in the last 2 weeks,
- •The subject is currently receiving systemic or topical Metronidazole or received in the last week,
- •The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,
- •The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour
研究组 & 干预措施
GK567
Experimental
GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g
干预措施: GK567 (Drug)
结局指标
主要结局
The Success Rate
时间窗: at Day 14 (end of treatment)
The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator
次要结局
- Smell Score by Investigator(on Days 0 (baseline), 7, and 14)
- Smell Score by Nurse(on Days 0 (baseline), 7, and 14)
- Smell Score by Patient(on Days 0 (baseline), 7, and 14)
- Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)(on Days 0 (baseline), 7, and 14)
- Pain (Visual Analogue Scale)(on Days 0 (baseline), 7, and 14)
研究者
研究点 (1)
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