ACTRN12621001403820终止2 期
A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)
niversity of Technology Sydney0 个研究点目标入组 4 人开始时间: 2021年10月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Advanced cancer;
- •Clinically confirmed bowel obstruction at any level with vomiting that precipitates a hospital admission or change in clinical care;
- •Deemed by two consultant level medical practitioners that this person has a bowel obstruction (partial or complete) for which immediate surgery is not indicated;
- •Disease-modifying therapy (surgery, chemotherapy, radiotherapy, hormone therapy; biological/targeted therapies) is deemed by relevant practitioners unlikely to change the bowel obstruction;
- •If participant has a nasogastric tube (NGT), final decompression must be at least 12 hours before treatment start;
- •Participant is capable of completing assessments and complying with the study procedures;
- •Record a St Louis Mental Status Exam Score (SLUMS) of greater than or equal to 23 or as deemed suitable by the site principal investigator; and
- •Participant is able to give fully informed, written consent.
排除标准
- •Previous adverse reaction to any of the study medications;
- •Calculated creatinine clearance <10 mL / min using the Modification of Diet in Renal Disease Study (MDRD) formula;
- •Venting or feeding gastrostomy or jejunostomy;
- •Participant has a NGT that, in the investigator’s opinion, cannot be clamped for the duration of treatment; and
- •Oral food intake that cannot be reduced to clear fluids
研究者
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