NCT00771485已完成2 期
Study of Efficacy of Bowel Preparation Before Colonoscopy
C.B. Fleet Company, Inc.3 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Effectiveness of bowel cleansing assessed by the examining physician
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
- •Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
- •Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
- •Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.
排除标准
- •Have any known contraindications to the study procedures or treatment,
- •Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
- •Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
- •Have any history of prior colon surgery,
- •History of active inflammatory bowel disease,
- •Have clinical evidence of dehydration,
- •Are pregnant or breast-feeding,
- •Are unwilling to abstain from alcohol consumption from the day before colonoscopy until discharged from the study,
- •Are unwilling to use any prohibited medications, including laxatives, 4 days before receiving the first study dose,
- •Have received any investigational agent within 30 days before dosing,
- •Have any known or suspected allergies, sensitivity or an unwillingness to consume components of the study medication,
- •Known or suspected phenylketonuria (PKU) or sensitivity to products containing phenylalanine, or is on a phenylalanine-reduced diet,
- •A history of hemolysis or taking concomitant medications known to precipitate hemolytic reactions,
- •Have any other condition which in the Investigator's opinion would make the subject unsuitable for inclusion into the study.
研究组 & 干预措施
1
Experimental
干预措施: FM-602 (Drug)
2
Other
干预措施: Marketed Bowel Cleanser (Drug)
结局指标
主要结局
Effectiveness of bowel cleansing assessed by the examining physician
时间窗: During colonoscopy
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Efficacy Study of Bowel Preparation Before ColonoscopyBowel Cleansing Prior to ColonoscopyNCT00621920C.B. Fleet Company, Inc.72
已完成
不适用
Bowel Preparation and Pelvic Organ Prolapse SurgeryPelvic Organ ProlapseNCT00937430TriHealth Inc.40
招募中
不适用
A prospective study of bowel preparation for colonoscopyDiseases of the digestive systemKCT0000952Inje University Ilsan Paik Hospital381
已完成
4 期
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal SurgeryIleusSurgeryConstipationNCT01879605Oslo University Hospital45
已完成
不适用
EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIESColorectal SurgeryPediatricBowel PreparationNCT06745505Shaheed Zulfiqar Ali Bhutto Medical University62