A placebo-controlled trial with citalopram for the treatment of typical reflux symptoms in patients with reflux hypersensitivity or functional heartburn with incomplete proton pump inhibitor response

Targid, KU Leuven0 个研究点目标入组 100 人开始时间: 2018年2月12日最近更新: 2018年8月20日

试验速览

暂无简介。

•- Age: between 18 and 75 years old
•- Proven reflux on a 24 hour pH-impedance montoring or esophagitis > grade A
•- History of 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
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Endoscopic signs of severe erosive esophagitis (= grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
•- Systemic diseases, known to affect esophageal motility.
•- Surgery in the thorax or in the upper part of the abdomen.
•- Treatment with citalopram prior to the start of the study.
•- Major psychiatric disorder.
•- Regular use of medications such as: anticholinergics, tricycle antidepressants.
•- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. - Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
•- Pregnancy or breast feeding.

发起方

Targid, KU Leuven