A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)

Interventions: Crushed Famotidine tablet for oral consumption, 40 mg every 24 hours for 5 days, within 24 hours of baseline assessments, administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence.
Crushed Dexamethasone for oral consumption, 8mg once per day in the morning for 5 days and to be commenced before midday on the first day or the next morning (if baseline assessments are completed in the afternoon), administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence.
Isotonic fluid administered as a parenteral infusion, at 10 – 20 mL / kg / 24-hours, commenced on on completion of the baseline assessments (unless dehydrated at the time the study is commenced where the treating clinician’s discretion may be used in the first 24 hours).
Primary outcome(s): The primary outcome is whether this study is feasible to extend to a fully powered phase III clinical trial.
Feasibility is defined as:
1.An average of one participant identified per site every eight weeks using recruitment tracking data bases;
2.One participant recruited per site every 12 weeks using recruitment racking databases; and
3.Collect data for >80% of people randomised, to the primary endpoint of 120 hours or study exit assessed by reviewing the data entry into the study data base..
[On completion of the study
]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

干预措施：压碎的法莫替丁（Famotidine）片剂供口服使用，每24小时给药40mg，持续5天，需在基线评估后24小时内给药，以酸奶或苹果泥等浓稠液体送服。由护理人员执行给药，需见证给药过程并在用药记录中登记，以病历作为依从性记录依据。
压碎的地塞米松（Dexamethasone）供口服使用，每日早晨单次给药8mg，持续5天，需在首日午前开始给药；若基线评估于下午完成，则可延后至次日早晨开始给药，同样以酸奶或苹果泥等浓稠液体送服。由护理人员执行给药，需见证给药过程并在用药记录中登记，以病历作为依从性记录依据。
等渗液体以静脉输注方式给药，剂量为10–20 mL/kg/24小时，于基线评估完成后开始输注；若研究入组时受试者已存在脱水情况，则前24小时可由治疗医师酌情调整给药方案。
主要结局指标：本研究的主要结局为该研究是否具备推广至具有足够统计效力的III期临床试验的可行性。
可行性定义如下：
1. 依托招募追踪数据库，每个研究中心每8周平均招募1名受试者；
2. 依托招募追踪数据库，每个研究中心每12周招募1名受试者；
3. 对≥80%的随机化受试者收集数据，直至其达到120小时的主要终点或退出研究，数据收集情况通过查阅研究数据库的录入信息进行评估。
[研究完成时]
研究设计：研究目的：治疗性研究；分配方式：随机对照试验；设盲：采用盲法；分组方式：平行分组；终点类型：安全性/有效性