NCT00779649已完成4 期
MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.
Research Associates of New York, LLP0 个研究点目标入组 220 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 主要终点
- The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire.
研究概览
简要总结
A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.
详细描述
To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults 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
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has provided written informed consent.
- •Is scheduled for colonoscopy within 30 days of screening
- •Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
- •Is able to communicate effectively with study personnel.
排除标准
- •Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
- •Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
- •History of renal insufficiency
结局指标
主要结局
The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire.
时间窗: one year from the trial start date
次要结局
未报告次要终点
研究者
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