EUCTR2012-004540-29-SE进行中（未招募）1 期
Injection treatment of ranula with OK 432 - A prospective, randomized, placebo controlled, double-blind study
Karolinska University Hospital0 个研究点开始时间: 2013年2月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women with ranula, aged 7 years and above
- •2. Be able to understand (if children <18: both parents understand) study concepts and comply to study visits and signed informed consent (both parents must sign informed consent if patient is yonger than 18 years old).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Younger than 7 years old.
- •2. Allergy to study drug excipients
- •2. Allergy to pencillin
- •3. Pregnant or breastfeeding (or are about to plan pregnancy)
- •4. Are dependent on immunomodulating substances, e.g.cytostatics.
- •5. Are dependent on corticosteroids (systemic use ) or regulary use of antiinflammatory drugs.
- •6. Have any reason, which in the opinion of the Principal Investigator would prevent the subject from safely participate in the study or complying with the protocol.
研究者
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