The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,249
- 试验地点
- 19
- 主要终点
- To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
研究概览
简要总结
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, aged between 50 and
- •Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
- •Able to comprehend the full nature and purpose of the study, including possible risks and side effects.
- •Able to co-operate with the investigator and to comply with the requirements of the entire study.
- •Signed written informed consent prior to inclusion in the study.
排除标准
- •Patients at high risk of colorectal cancer e.g. ulcerative colitis
- •Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.
- •Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
- •Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
研究组 & 干预措施
Methylene Blue MMX® 200mg
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
干预措施: Methylene Blue MMX® (Drug)
Methylene Blue MMX® 100mg
Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
干预措施: Methylene Blue MMX® (Drug)
Methylene Blue MMX® 100mg
Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
干预措施: Placebo (Drug)
Placebo
Oral dose, 8 Placebo tablets over a 4hr schedule
干预措施: Placebo (Drug)
结局指标
主要结局
To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
时间窗: +7 days
Adenoma Detection Rate
次要结局
未报告次要终点