Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Treatment satisfaction assessed by the VAS
研究概览
简要总结
This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).
详细描述
After being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20mL, once daily). Treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators were not masked to group assignment. An independent statistician was masked for the data analysis.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients
- •Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome Ⅲ criteria)
- •Diagnosis of IBS-C (Rome Ⅲ criteria)
排除标准
- •Helicobacter Pylori infection
- •GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
研究组 & 干预措施
linaclotide
Patients in linaclotide group were given with oral, once daily 290 μg linaclotide for consecutively 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Linaclotide (Drug)
linaclotide
Patients in linaclotide group were given with oral, once daily 290 μg linaclotide for consecutively 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Omeprazol (Drug)
linaclotide
Patients in linaclotide group were given with oral, once daily 290 μg linaclotide for consecutively 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Itopride (Drug)
lactulose
Patients in Lactulose group were given with oral, once daily 20 mL Lactulose for 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Lactulose (Drug)
lactulose
Patients in Lactulose group were given with oral, once daily 20 mL Lactulose for 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Omeprazol (Drug)
lactulose
Patients in Lactulose group were given with oral, once daily 20 mL Lactulose for 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.
干预措施: Itopride (Drug)
结局指标
主要结局
Treatment satisfaction assessed by the VAS
时间窗: Week 4
Treatment satisfaction will be assessed by the Visual Analogue Scale: score 0=not at all, 1=partial relief of general GI symptoms, 2=complete relief of general GI symptoms.
次要结局
- Changes in stool consistency(Baseline and Week 4)
- Changes in defecation time(Baseline and Week 4)
- Changes in the depression status(Baseline and Week 4)
- Changes in defecation straining score(Baseline and Week 4)
- Changes in sensation of complete evacuation(Baseline and Week 4)
- Changes in stool frequency(Baseline and Week 4)
- Changes in lower abdominal discomfort(Baseline and Week 4)
- Changes in lower abdominal pain(Baseline and Week 4)
- Changes in FD symptoms(Baseline and Week 4)
- Changes in the anxiety status(Baseline and Week 4)
研究者
Shengliang Chen
professor,chief physician
RenJi Hospital