NCT00503607已完成3 期
A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Braintree Laboratories11 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Efficacy - preparation quality using a 4 point scale
研究概览
简要总结
This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 a routinely accepted indication, including:
- •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, 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects who are undergoing colonoscopy for foreign body removal and decompression.
- •Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- •Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
- •Subjects who had previous gastrointestinal surgeries
- •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
时间窗: 2-Day
次要结局
- Safety - preparation related side effects; laboratory analysis(30-Day)
研究者
研究点 (11)
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