NCT03746691

Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Effect of Citalopram on Fasting and Postprandial Lower Esophageal Sphincter Function in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DRUG	Citalopram HCl	Citalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
DRUG	Placebos	Placebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2018-11-20
• Last updated: 2018-11-20

Locations

1 site across 1 country: Belgium