2024-516317-21-00招募中4 期
A placebo-controlled trial with prucalopride for the treatment of typical reflux symptoms in patients with gastro-esophageal reflux disease with incomplete proton pump inhibitor response.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in acid exposure time assessed by 24 hour impedance-pH monitoring
研究概览
简要总结
To assess the efficacy of prucalopride 2mg 4 weeks add-on treatment in patients with gastro-esophageal reflux disease and an incomplete response to PPI therapy
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old.
- •Patients must have proven reflux, documented either by the presence of esophagitis (≥ grade B) at upper endoscopy (“on” PPI b.i.d.) in the 24 months prior to inclusion or pathological reflux parameters (acid exposure time >4% or number of reflux episodes >40) on a 24 hour impedance-pH monitoring (“on” PPI b.i.d.) in the 6 months prior to inclusion.
- •History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
- •Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
- •Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception do not include oral contraceptives, due to expected diarrhea as side effect of prucalopride. Injectable or implantable methods, intrauterine devices, or properly used barrier contraception are acceptable forms of contraception.
- •Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
排除标准
- •Systemic diseases, known to affect esophageal motility.
- •Colitis ulcerosa, Crohn’s disease, toxic megacolon.
- •Have a cardiovascular disease or QTc >450 ms
- •Severely decreased kidney function.
- •Severely decreased liver function.
- •Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- •Number of stools >3 per day.
- •Treatment with prucalopride prior to the start of the study.
- •Concomitant use of medications such as: anticholinergics, baclofen or prokinetics.
结局指标
主要结局
Change in acid exposure time assessed by 24 hour impedance-pH monitoring
Change in acid exposure time assessed by 24 hour impedance-pH monitoring
次要结局
- Change in number of reflux episodes assessed by 24 hour impedance-pH monitoring
- Change in motility patterns in the esophagus assessed by high resolution and impedance manometry
- Change in symptom severity assessed by a reflux questionnaire (Request)
研究者
Jan Tack
Scientific
UZ Leuven
研究点 (3)
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