NCT00756977已完成3 期
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Braintree Laboratories12 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2008年8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
- 394
- 试验地点
- 12
- 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 BLI850 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
- 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, including:
- •Evaluation of barium enema results
- •GI bleeding
- •Anemia of unknown etiology
- •Neoplastic disease surveillance
- •Abnormal 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 or decompression.
- •Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- •Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
- •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 surgical, drug, or device study within the past 30 days.
研究组 & 干预措施
1
Experimental
multi-dose preparation for oral administration prior to colonoscopy
干预措施: BLI850 (Drug)
2
Active Comparator
multi-dose preparation for oral administration prior to colonoscopy
干预措施: polyethylene glycol 3350 based bowel preparation (Drug)
结局指标
主要结局
Efficacy - Preparation Quality Using a 4 Point Scale
时间窗: 2-day
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
次要结局
- Serum Chemistry Results (mg/dL)(2 days)
- Hematology Results (%)(2 days)
- Serum Chemistry Results (U/L)(2 days)
- Serum Chemistry Results (mEq/L)(2 days)
- Serum Chemistry Results (g/dL)(2 days)
- Serum Chemistry Results (GFR)(2 days)
- Hematology Results (1000/MCL)(2 days)
- Hematology Results - Hemoglobin(2 days)
- Hematology Results - Red Blood Cells(2 days)
- Serum Chemistry Results (Osmolality)(2 days)
研究者
研究点 (12)
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