To compare the efficacy and safety of elobixibat and prucalopride in patients with chronic constipation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Increase in the number of complete spontaneous bowel movements (CSBMs) per week.
研究概览
简要总结
This prospective, observational, multi-center study aims to compare the efficacy of elobixibat and prucalopride in increasing complete spontaneous bowel movements (CSBMs) in patients with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C) over an eight-week treatment period. The study includes adults diagnosed per Rome IV criteria who have failed conventional treatments for at least three months.
The primary outcome is the increase in CSBMs per week over eight weeks. Several secondary outcomes will also be assessed, including stool consistency, time to first CSBM, patient-reported symptom relief, patient satisfaction, rescue medication use, adverse events, and degree of straining during defecation.
Assessments will occur at baseline, four weeks, and eight weeks for stool consistency and symptom relief, while time to first CSBM will be recorded during the first week of treatment. Patient satisfaction will be evaluated at eight weeks, and rescue medication use and adverse events will be monitored throughout the study. The severity of straining during defecation will be assessed at baseline and at eight weeks.
The target sample size consists of 150 participants in India, and the estimated duration of the study is 6 months from the first enrollment to the final analysis. By comparing elobixibat and prucalopride, this study aims to generate real-world evidence on their effectiveness in improving bowel movement frequency, symptom relief, and patient satisfaction while ensuring safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) Adults aged 18 years to 65 years.
- •(2) Diagnosed with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C) as per Rome IV criteria.
- •(3) History of inadequate response to conventional treatments for constipation for at least three months; and have been prescribed Elobixibat or Prucalopride by the treating physician (4) Willing and able to provide written informed consent.
- •(5) Willing to comply with study procedures, including follow-up visits and assessments over the study period.
排除标准
- •(1) Presence of secondary causes of constipation, including metabolic (e.g., hypothyroidism, diabetes mellitus), neurological (e.g., Parkinson’s disease, multiple sclerosis), or drug-induced constipation.
- •(2) Evidence of organic gastrointestinal diseases such as inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, or strictures.
- •(3) History of major abdominal surgery affecting gastrointestinal motility, except for uncomplicated appendectomy, cholecystectomy, or hysterectomy.
- •(4) Use of laxatives, enemas, prokinetics, opioids, or other constipation-related medications within two weeks prior to enrollment.
- •(5) Known hypersensitivity or contraindications to elobixibat or prucalopride.
- •(6) Severe psychiatric disorders (e.g., major depression, schizophrenia) that may interfere with study participation or compliance.
- •(7) Pregnancy or lactation.
- •(8) Severe cardiovascular diseases, including uncontrolled hypertension or a history of myocardial infarction.
- •(9) Any other severe systemic illness that could impact gastrointestinal motility or study outcomes (e.g., chronic kidney disease stage IV-V, advanced liver disease).
- •(10) Participation in another clinical trial within the past three months.
结局指标
主要结局
Increase in the number of complete spontaneous bowel movements (CSBMs) per week.
时间窗: 8 weeks
次要结局
- Stool consistency (Bristol Stool Form Scale)(Time to first CSBM)