NCT00621920已完成2 期
Efficacy Study of Bowel Preparation Before Colonoscopy
C.B. Fleet Company, Inc.4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Effectiveness of bowel cleansing based on a grading scale.
研究概览
简要总结
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
- •Are able to communicate with study personnel and comply with study requirements.
- •Are able and willing to follow study-specified testing, diet, and hydration regimen.
- •Have been informed of the nature and risks of the study and have given written informed consent.
排除标准
- •Have known or suspected liver disease or any history of abnormal liver function tests.
- •Have clinically active cardiovascular disease within the past 6 months.
- •Have blood pressure greater than 150/90 mm Hg.
- •Have known or suspected renal insufficiency.
- •Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
- •Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
- •Have diabetes or a history of diabetes.
- •Have clinical evidence of dehydration.
- •Are pregnant or breast-feeding.
- •Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
- •Use prohibited medications of the study in the defined timeframes.
- •Have received any investigational agent within 30 days before dosing.
- •Have any known contraindications to the study treatment.
- •Have any known or suspected allergies to the components of the study medication.
- •Have any other condition which would make the subject unsuitable for inclusion in the study.
结局指标
主要结局
Effectiveness of bowel cleansing based on a grading scale.
时间窗: During colonoscopy
次要结局
未报告次要终点
研究者
研究点 (4)
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