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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004174-34-BE

Enrollment

100

Registered

2018-02-12

Start date

2018-04-10

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional heartburn and reflux hypersensitivity with incomplete respons to proton pomp inhibitors

Interventions

Trade Name: Cipramil 20mg Product Name: Cipramil Pharmaceutical Form: Coated tablet INN or Proposed INN: citalopram CAS Number: 59729-32-7 Other descriptive name: CITALOPRAM HYDROBROMIDE Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of Citalopram on reflux parameters, reflux symptoms and esophageal sensitivity for 8 weeks treatment in patients with reflux hypersensitivity or functional heartburn with incomplete response to PPI therapy;Secondary Objective: To assess the predictive value of reflux assessment, the assessment of esophageal sensitivity and questionnaire results on the primary outcome;Primary end point(s): - Change in symptom severity assesed by reflux questionnaires - Change in reflux parameters assessed by 24 hour impedance-pH - Change in esophageal sensitivity assessed by a multimodal esophageal stimulation procedure ;Timepoint(s) of evaluation of this end point: After 8 weeks of citalopram intake	—

Measure

Time frame

Main Objective: To assess the efficacy of Citalopram on reflux parameters, reflux symptoms and esophageal sensitivity for 8 weeks treatment in patients with reflux hypersensitivity or functional heartburn with incomplete response to PPI therapy;Secondary Objective: To assess the predictive value of reflux assessment, the assessment of esophageal sensitivity and questionnaire results on the primary outcome;Primary end point(s): - Change in symptom severity assesed by reflux questionnaires - Change in reflux parameters assessed by 24 hour impedance-pH - Change in esophageal sensitivity assessed by a multimodal esophageal stimulation procedure ;Timepoint(s) of evaluation of this end point: After 8 weeks of citalopram intake

—

Secondary

Measure	Time frame
Secondary end point(s): - Predictive value of reflux assessment - Predictive value of assessment of esophageal sensitivity ;Timepoint(s) of evaluation of this end point: After 8 weeks of citalopram intake	—

Countries

Belgium

Contacts

Public ContactTargid

Targid, KU Leuven

hannelore.geysen@kuleuven.be+32016324921

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026