NCT00856843已完成3 期
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Braintree Laboratories5 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2009年2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
- 136
- 试验地点
- 5
- 主要终点
- Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
研究概览
简要总结
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
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
- •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
- •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 gastrointestinal surgeries.
- •Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- •Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- •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
Polyethylene glycol 3350 based bowel preparation
Active Comparator
Polyethylene glycol 3350 based bowel preparation
干预措施: Polyethylene glycol 3350 based bowel preparation (Drug)
BLI800
Experimental
BLI800
干预措施: BLI800 (Drug)
结局指标
主要结局
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
时间窗: 2 days
Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
次要结局
- Assessment of Residual Stool - Cecum(2 days)
- Assessment of Residual Fluid - Ascending Colon(2 days)
- Assessment of Residual Stool - Ascending Colon(2 days)
- Assessment of Residual Stool - Transverse Colon(2 days)
- Assessment of Residual Stool - Descending Colon(2 days)
- Assessment of Residual Stool - Sigmoid Colon/Rectum(2 days)
- Assessment of Residual Fluid - Cecum(2 days)
- Assessment of Residual Fluid - Transverse Colon(2 days)
- Assessment of Residual Fluid - Descending Colon(2 days)
- Assessment of Residual Fluid - Sigmoid Colon/Rectum(2 days)
- Subject Symptom Scores(2 days)
- Mean Change in Serum Chemistry (mg/dL)(up to 15 days)
- Mean Change in Serum Chemistry (mEq/L)(up to 15 days)
研究者
研究点 (5)
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