NCT01501513已完成3 期
A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency
Braintree Laboratories17 个研究点 分布在 1 个国家目标入组 541 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 541
- 试验地点
- 17
- 主要终点
- Percentage of Subjects With Successful Bowel Preparation
研究概览
简要总结
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
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 (Outcomes Assessor)
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 a routinely accepted indication.
- •At least 18 years of age
- •If female, and of child-bearing potential, is using an acceptable form of birth control
- •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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- •Subjects who had previous significant gastrointestinal surgeries.
- •Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
- •Subjects with severe liver or renal insufficiency.
- •Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects undergoing colonoscopy for foreign body removal and decompression.
- •Subjects who are pregnant or lactating, or intending to become pregnant during the study.
- •Subjects of childbearing potential who refuse a pregnancy test.
- •Subjects 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 surgical, drug, or device study within the past 30 days.
研究组 & 干预措施
BLI800 approved preparation regimen
Experimental
BLI800 approved preparation regimen
干预措施: BLI800 approved preparation regimen (Drug)
BLI800 investigational preparation regimen
Experimental
BLI800 investigational preparation regimen
干预措施: BLI800 investigational preparation regimen (Drug)
PEG-3350 based bowel preparation
Active Comparator
PEG-3350 based bowel preparation
干预措施: PEG-3350 based bowel preparation (Drug)
结局指标
主要结局
Percentage of Subjects With Successful Bowel Preparation
时间窗: Day of colonoscopy
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
次要结局
- Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy(2 days)
- Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7(7 days)
研究者
研究点 (17)
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