EUCTR2013-001248-67-ES进行中（未招募）不适用
CLINICAL TRIAL PHASE IIIb to evaluate predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms - linaclotide
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- almirall
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. Age betwen 18 and 70 years old
- •2. Sex: male and female
- •3. Meet the Rome III criteria for the diagnosis of constipation predominant IBS
- •4. Moderate-severe constipation IBS, defined as a score greater than 175 points IBSSS
- •5. Clinical explorations to support the diagnosis of IBS:
- •a. All patients: blood in less than six months that shows no anemia
- •b. Over 50 years: colonoscopy to the cecum without abnormalities explaining the symptoms in the last five years.
- •6. Sign informed consent: Patients should give informed consent in writing and must be able to read and understand it.
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Women of childbearing age who are unwilling or unable to use valids methods of contraception during the study period and up to 4 weeks after finishing.
- •2. Women of childbearing age who use an invalid method of contraception.
- •3. Pregnant or breast-feeding.
- •4l. Women with a positive pregnancy test at the time of enrollment or prior to study drug administration.
研究者
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