EUCTR2018-001914-13-BE进行中（未招募）1 期
Clinical Trial to Evaluate the Efficacy and Safety of MACRORANGE® in Patients Suffering from Functional Constipation
Salsarulo Pharma0 个研究点目标入组 30 人开始时间: 2018年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •Age of the patients: = 18 years of age;
- •Male and female patients;
- •Stool frequency < 3 per week;
- •Functional constipation as defined in constipation module of ROME III
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Irritable Bowel Syndrome (IBS specifically type C);
- •Hypersensitivity to the active substances or any excipients;
- •Organic inflammatory bowel disease (ulcerative rectocolitis, Crohn’s disease);
- •Toxic megacolon;
- •Gastrointestinal obstruction or subocclusive syndromes;
- •Allergic to aspartame;
- •Painful abdominal syndromes of undetermined origin;
- •Existing partial colectomy or bariatric surgery (gastric bypass type);
- •Presumed non-cooperativeness;
- •Concomitant treatment from start of wash-out period until discharge from the study with any medication that may alter the gastrointestinal motility (see section 6.2.2) in the opinion of the Investigator;
- •Legal incapacity;
- •Any clinical condition which does not justify study participation in the Investigator's opinion;
- •Participation = 8 weeks in a clinical trial;
- •Parallel participation in a clinical trial;
- •Repeated participation in this clinical trial.
研究者
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