NCT00425594已完成4 期
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Braintree Laboratories26 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年1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
- 150
- 试验地点
- 26
- 主要终点
- Efficacy - preparation quality using a 4-point scale
研究概览
简要总结
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
- •Evaluation of BE results
- •Endosonography
- •Blood in stool
- •Anemia of unknown etiology
- •Abdominal Pain
- •Polypectomy
- •Unknown diarrhea or constipation etiology
- •Inflammatory bowel disease
- •Between 6 and 16 years of age at screening.
- •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, parent/guardian 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 impacted at screening
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects who are undergoing colonoscopy for foreign body removal and decompression
- •Subjects with known difficulties for swallowing tablets
- •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 with the exception of routine diuretics.
- •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.
- •Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
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. Pre and post preparation analysis of serum chemistry.
研究者
研究点 (26)
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