EUCTR2017-003505-17-IT进行中（未招募）1 期
Colonic lesion staining and flagging efficacy of methylene blue administered as MMX® 25 mg modified release tablets to patients receiving a split dose regimen of bowel cleansing preparation for colonoscopy - Colonic lesion staining and flagging efficacy of methylene blue in patients receiving a bowel cleans
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Sex and Age: men and women, = 50 years old inclusive
- •3. Indication: outpatients scheduled for screening or surveillance colonoscopy
- •4. Contraception: women of childbearing potential must use at least one reliable method of contraception or be abstinent. Women of non-childbearing potential or in post-menopausal status must have been in that status for at least 1 year. For all women of childbearing potential, serum pregnancy test result must be negative at screening.
- •5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Pregnancy: pregnant or lactating women or women undergoing fertility treatment or women at risk of becoming pregnant or women with a positive pregnancy test, if applicable.
- •2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study.
- •3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness; in particular, ALT, AST, ¿-GT, bilirubin, creatinine or urea greater than 2.5 x the upper limit for normal, based on laboratory testing.
- •4. Allergy: ascertained or presumptive hypersensitivity to methylene blue and/or ingredients of Methylene Blue MMX® tablets or PEG-based bowel cleansing preparations; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
- •5. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major known colonic resection, severe known diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, clinical alarm symptoms or history of anaemia (previously recorded haemoglobin of less than 10mg/dL), frank blood in the stool within the last 30 days prior to enrolment, known deficiency of glucose-6-phosphate dehydrogenase, known deficiency of NADPH reductase, methaemoglobinemia and any other medical condition that in the investigator’s opinion would make the administration of the study drug or procedures hazardous to the patient.
- •6. Medications: previous or concomitant treatment with any serotonergic psychiatric medications within 2 weeks before the study, in accordance with a drug safety alert published by FDA. In particular, previous or concomitant treatment with the selective serotonin reuptake inhibitors (paroxetine, fluvoxamine, sertraline, citalopram, escitalopram, vilazodone etc.), the serotonin-norepinephrine reuptake inhibitors (venlafaxine, devenlafaxine, duloxetine), tricyclic antidepressants (amitriptyline, desipramine, clomipramine, imipramine, nortriptyline, protriptyline, doxepin, trimipramine), monoamine oxidase inhibitors (isocarboxazid, phenelzine, transdermal selegiline, tranylcypromine, etc.) and other psychiatric drugs (amoxapine, maprotiline, nefazodone, trazodone, bupropion, buspirone, vilazodone, mirtazapine) within 2 weeks before the study, previous or concomitant treatment with fluoxetine within 5 weeks before the study and/or previous or concomitant treatment with anticoagulants or antiaggregants inducing an INR>1.5.
研究者
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