A trial to investigate the effect of citalopram for the treatment of typical reflux symptoms

Phase 1

• Conditions: Functional heartburn and reflux hypersensitivity with incomplete respons to proton pomp inhibitors; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2017-004174-34-BE
• Lead Sponsor: Targid, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-12
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified