NCT00278967已完成4 期
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Braintree Laboratories10 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- Efficacy - preparation quality using a 4-point scale
研究概览
简要总结
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
详细描述
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for 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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:
- •Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
- •At least 18 years of age
- •Otherwise in good health, as determined by physical exam and medical history
- •If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
- •Negative urine pregnancy test at screening, if applicable
- •In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
排除标准
- •Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration
- •Subjects who are undergoing colonoscopy for foreign body removal and decompression
- •Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
- •Subjects who are taking drugs that may affect electrolyte levels
- •Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
- •Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
- •Subjects who are pregnant or lactating, or intending to become pregnant during the study
- •Subjects of childbearing potential who refuse a pregnancy test
- •Subjects who are allergic to any preparation components
- •Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
- •Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
结局指标
主要结局
Efficacy - preparation quality using a 4-point scale
次要结局
- Safety - patient-reported preparation related side-effects
研究者
研究点 (10)
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