ACTRN12616000602426尚未招募1 期
Thioguanine Suppositories For Proctitis. An Open Label Phase I Study To Evaluate the Efficacy and Safety of TG as a suppository
Mater Hospital Brisbane0 个研究点目标入组 10 人开始时间: 2016年5月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Patients to include in the study will be screened from:
- •a.Patients attending Gastroenterology outpatient clinics.
- •b.Pre-existing clinical databases in the department of Gastroenterology and Dr Florin’s private rooms at Mater Health Services, South Brisbane.
- •2.All patients satisfying the criteria for severe proctitis will be screened and will need to meet the below inclusion and exclusion criteria.
- •a) Able to give informed consent
- •b) Age 18 and above
- •c) Clinical evidence of severe proctitis: Established diagnosis of severe Proctitis (isolated proctitis proven at a colonoscopy within 3 months of consenting and with Mayo endoscopic subscore greater than or equal to 2.)
- •d) patients who have failed the ‘standard’ combination of oral and rectal 5-ASA at the time of the consenting process as demonstrated by a partial Mayo Score greater than 3 while on standard treatment.
排除标准
- •Pregnant women
研究者
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