EUCTR2012-003983-32-IT进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females, aged between 50 and 75.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 635
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 635
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.
- •ALT, AST, GGT, Bilirubin, Creatinine or Urea greater than 2.5 x the upper limit for normal range, based on local laboratory testing.
- •The presence of serious cardiovascular disease, including very large abdominal aortic aneurysms (particularly if they are symptomatic), patients who are immediately postoperative, and patients who have suffered recent myocardial infarction (within 3 weeks), pulmonary embolism, or are currently hemodynamically unstable.
- •The presence of liver disease with coagulopathy
- •A history of anaemia (previously recorded haemoglobin of less than 10mg/dL) within the last 30 days prior to enrollment.
- •Known evidence of glucose-6-phosphate deficiency,
- •Known deficiency of NADPH reductase
- •Treatment within 5 weeks prior to randomisation with Fluoxetine (Prozac).
- •Concurrent treatment, or previous treatment within 2 weeks with any of the prohibited psychiatric medications that may interact with Methylene Blue as listed under Prohibited medications; Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinepherine Reuptake Inhibitors (SNRI’s), listed Tricyclic anti-depressants or Monoamine oxidase A inhibitors.
- •Current enrollment in any other clinical trial, or previous enrollment in a clinical trial within the last 30 days.
- •Other medical condition that in the investigators opinion would make the administration of the study drug or procedures hazardous to the subject.
研究者
相似试验
进行中（未招募）
1 期
The safety and effectiveness of Methylene Blue MMX® tablets given to patients undergoing screening or surveillance colonoscopy.EUCTR2012-003983-32-DECosmo Technologies Ltd1,270
进行中（未招募）
1 期
The safety and effectiveness of Methylene Blue MMX® tablets given to patients undergoing screening or surveillance colonoscopy.EUCTR2012-003983-32-LTCosmo Technologies Ltd1,270
已完成
3 期
The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.10017987Polyp and adenoma detection during colonoscopy. Abnormal growth of tissue detection during colonoscopyNL-OMON41630Cosmo Technologies Ltd272
进行中（未招募）
1 期
The safety and effectiveness of Methylene Blue MMX® tablets given to patients undergoing screening or surveillance colonoscopy.EUCTR2012-003983-32-BECosmo Technologies Ltd1,270
进行中（未招募）
1 期
The safety and effectiveness of Methylene Blue MMX® tablets given to patients undergoing screening or surveillance colonoscopy.EUCTR2012-003983-32-NLCosmo Technologies Ltd1,270