EUCTR2006-005642-37-BE进行中（未招募）1 期
Sandostatin® in the treatment of diarrhea in patients with ileal pouch anal anastomosis. - pouchitis
niversity of Leuven, Division of Gastroenterology0 个研究点目标入组 60 人开始时间: 2007年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •- Patients with IPAA, who have had a functioning pouch without ileostomy for at least 6 months.
- •- A stool frequency of 7 or more loose stools in 24 hrs. for at least 7 consecutive days
- •prior to inclusion.
- •- Stable dose of loperamide or antibiotics for at least 7 days prior to inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Evidence of ongoing or recent (within 14 days) enteritis or positive stool culture for
- •enteric pathogens or C difficile toxin positivity.
- •- Short bowel syndrome.
- •- Pouch related fistula or stenosis of pouch outlet.
- •- Female patients who are pregnant or lactating, or are of childbearing potential and not
- •practicing a medically acceptable method for birth control.
- •- Known allergy to Sandostatin? or one of its compounds.
- •- Symptomatic cholelithiasis
- •- Poorly controlled Diabetes Mellitus : Hba1c > 10 %.
研究者
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