Open Study to Assess the Tolerability, Safety and Efficacy of an Adapted 2 Litre Gut Cleansing Solution (NRL0706) in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumour Screening.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Norgine
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall Acceptance on VAS (100mm) rating
研究概览
简要总结
It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.
Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 单组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- The subject's written informed consent must be obtained prior to inclusion.
- Male or female ambulatory subjects aged between 40 to 75 years undergoing a complete colonoscopy for colon cancer screening.
- No history of significant gastrointestinal diseases, including gastrointestinal obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
- Willing to undergo a colonoscopy for colon cancer screening.
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
- Females of childbearing potential must employ an adequate method of contraception.
排除标准
- History of gastric emptying disorders
- History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation
- History of Phenylketonuria
- Known Glucose-6-phosphate dehydrogenase deficiency
- Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/ sodium ascorbate
- History of colonic resection
- Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
- Presence of congestive heart failure (NYHA III + IV)
- Acute life-threatening cardiovascular disease
- Documented history of severe renal insufficiency
- Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months
- Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
- Subjects who the investigator feels would not be compliant with the requirements of the trial
研究组 & 干预措施
Moviprep Orange
All patients receive 2 litres of NRL0706 solution.
干预措施: NRL0706 (Drug)
结局指标
主要结局
Overall Acceptance on VAS (100mm) rating
时间窗: 12 hours
次要结局
- Acceptability rated by compliance, four-point VRS and VAS (100mm) rating(12 hours)
- Tolerance on five-point VRS(12 hours)
- Taste Evaluation on VAS (100mm) rating(12 hours)
- Efficacy on five-grade scale for pre-defined colon areas(12 hours)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT01251237
- 其他研究编号
- NRL0706-01/2009 (VOM), 2009-014845-95
日期
- 首次提交
- (15年前)
- 首次发布
- (15年前)
- 主要完成日期
- 研究完成日期
- 最近核实
- 最近更新
- (15年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否