NCT01427296已完成4 期
A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,154
- 主要终点
- Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 70 years of age, inclusive
- •Scheduled for colonoscopy within 21 days of the screening visit
- •Able to swallow tablets the size of a multivitamin without difficulty
排除标准
- •History of biopsy-proven acute phosphate nephropathy
- •Known allergy or hypersensitivity to treatment arms
- •History of gastric stapling or bypass procedure or history of gastric retention
- •History of any other sodium phosphate preparation within 6 months prior to colonoscopy
研究组 & 干预措施
OsmoPrep Tablets
Active Comparator
干预措施: Oral sodium phosphate solution (Drug)
HalfLytely and Bisacodyl Tablet
Active Comparator
干预措施: Polyethylene glycol (Drug)
结局指标
主要结局
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
时间窗: 6 months
次要结局
未报告次要终点
研究者
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