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 sites100 target enrollmentFebruary 12, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 12, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Targid, KU Leuven

•\- 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.