EUCTR2014-004687-37-GB进行中（未招募）1 期
se of Methylnaltrexone for the Treatment of Opioid Induced Constipation & Gastro-Intestinal Stasis in Intensive Care Patients - Methylnaltrexone for the Treatment of Opioid Induced Constipation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
- •Males and females = 18 years of age
- •Following ICU admission, sedated with opioids and requiring invasive ventilator support
- •Scheduled for continuous infusion/administration of opioid analgesics for at least a further 24 hours
- •Constipated (not opened bowels for a minimum 48 hours following ICU admission)
- •Access for enteral administration of medications and nasal-gastric tube feeds
- •Initiation of nasogastric tube feeds
- •Patient weight of 38-114kg (this allows pre preparation of drug with either 8mg or 12mg)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Known to be pregnant
- •Patients with end stage renal failure requiring dialysis on admission
- •Diarrhoea on admission
- •Abdominal surgery within 8 weeks prior to ICU admission
- •Presence of Ileostomy or colostomy
- •Mechanical gastrointestinal obstruction
- •Suspected Acute surgical abdomen
- •History of Crohn's disease or ulcerative colitis
- •On Palliative care or not expected to survive more than 12 hours
- •Severe chronic hepatic impairment (Child Pugh Class C)
- •Suspected hepatic encephalopathy
- •Known to have received another IMP within 30 days or currently in another interventional trial that might interact with the study drug or previously enrolled into MOTION
研究者
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