A Comparative Evaluation Of The Effectiveness And Safety Of Lubiprostone And Prucalopride In Patients With Chronic Idiopathic Constipation: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increase in Spontaneous Bowel Movement per week
研究概览
简要总结
A Randomized Controlled Trial in the department of Gastroenterology to evaluate Effectiveness and Safety of Lubiprostone Versus Prucalopride in Patient with Idiopathic Constipation.
All patient who satisfies the inclusion and exclusion criteria will be selected for the study.
Intervention (Prucalopride) and Comparator(Lubiprostone) treatment will be randomized and given to the patients, and data will be collected during follow up and via telecommunication
Data collection form will be completed
Data will be transferred to an excel sheet
Descriptive statistics will be used for analysis of the data.
Statistical Details
To test the statistically significant change in the frequency of spontaneous bowel movement per week, PAC-SYM score, Bristol Stool Scale, Naranjo’s causality assessment scale, Hartwig’s severity scale before and after between the two groups. Independent sample t-test for normal data or Mann- Whitney U test for skewed data will be applied
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with chronic idiopathic constipation Patients between ages 18 to 80 years( male and female).
排除标准
- •Patients with Mechanical bowel obstruction Patients with Drug Induced Constipation Secondary causes for constipation such as Hypothyroidism, Cardio vascular disease, Malignancies, etc.
- •Pregnant and Lactating women Other bowel disease such as IBD.
结局指标
主要结局
Increase in Spontaneous Bowel Movement per week
时间窗: Within 3 week of treatment
次要结局
- To determine any ADR and its severity(Within 3 weeks of treatment)
研究者
Dr Shine Sadasivan
Amrita Institute of Medical Sciences and Research Centre