2025-520818-65-00招募中3 期
Evaluation of the effectiveness and tolerance of the macrogol 3350 and electrolytes combination, as a second-line intestinal preparation regimen for colonoscopy with sodium picosulfate/magnesium citrate: a randomized, placebo-controlled, study (PICO-TRAT STUDY)
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.4 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2025年7月18日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.
研究概览
简要总结
The aim of the study is to evaluate the efficacy of the combination of CLINITRAT and PICOPREP medicinal products in bowel preparation before colonoscopy in patients with inadequate preparation at reference colonoscopy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Women and/or men at least 18 years old
- •Women and/or men with inadequate preparation on reference colonoscopy, score <6 points according to the Boston Bowel Preparation Scale (BBPS)
- •Patients who are legally competent and capable of understanding the information provided about the study, have been informed about the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).
排除标准
- •Common contraindications for colonoscopy (suspected perforation, toxic megacolon, pyloric stenosis, severe colitis, pregnancy, lactation)
- •Type I diabetes
- •Patients with colon segmental resection
- •Patients suffering from severe dehydration
- •Rhabdomyolysis
- •Hypermagnesemia
- •Patients suffering from active inflammatory bowel disease
- •Intestinal obstruction or perforation
- •Ileus, gastric retention, acute intestinal or gastric ulceration
- •Acute abdominal conditions requiring immediate surgery, such as acute appendicitis
- •Nausea and vomiting
- •Allergy or hypersensitivity to study drugs
- •Toxic megacolon
- •Non-compliance with instructions for bowel preparation during reference colonoscopy (receiving <75% of bowel preparation)
- •Polyposis syndrome and refusal to participate in the study
- •Participation in another study of an investigational medicinal product or investigational medical device
- •Severe heart failure (NYHA III/IV)
- •Severe chronic kidney disease (eGFR<30)
结局指标
主要结局
Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.
Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.
次要结局
- Average BBPS total score
- Partial BBPS sub-score for the right (ascending) colon
- Polyp detection rate
- Percentage of colonoscopies reaching the cecum
- Patient tolerance, which will be assessed based on a questionnaire assessing the tolerance of the preparation translated and updated in Greek
研究者
Georgios-Stefanos Soumelas
Scientific
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
研究点 (4)
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