Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Detected Intraepithelial Neoplasia
研究概览
简要总结
Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •endoscopically verified UC signed written informed consent
排除标准
- •Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.
研究组 & 干预措施
Patients with UC undergoing colonoscopy
干预措施: oral delivery mucosal stain (Device)
结局指标
主要结局
Detected Intraepithelial Neoplasia
时间窗: During colonscopy (usually <15 min) and subsequent histological analysis
Rate of intraepithelial neoplasiae detection in the whole colon.
Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)
时间窗: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)
时间窗: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)
时间窗: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)
时间窗: During colonscopy (usually <15 min) and subsequent histological analysis
The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.
次要结局
- The Extent and Severity of the Inflamed Mucosa(During colonscopy (usually <15 min) and subsequent histological analysis)
- The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.(During colonscopy (usually <15 min) and subsequent histological analysis)
- Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation(During colonscopy (usually <15 min))