Skip to main content
OpenTrials
Completed

NCT Number: NCT03746691

Effect of Citalopram on Reflux Episodes in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between 18 and 65 years

Exclusion criteria

  • history of upper GI symptoms
  • history of upper GI surgery
  • psychological disorders
  • any drug history
  • use of medication altering GI motility
  • nursing and pregnant woman

Treatment and study plan

Citalopram HCl

Drug

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.

Placebos

Drug

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.

Primary outcomes

  1. Change in LES pressure

    Time frame: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.

    The investigators will measure lower esophageal sphincter pressure after a meal between placebo and citalopram, using a high resolution impedance manometry system. LES pressures will be measured in the first hour postprandial and will be compared (preprandial vs postprandial hour 1).

  2. Change in the number of reflux episodes

    Time frame: The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.

    The investigators will measure the number of reflux episodes after a meal between placebo and citalopram, using a high resolution impedance manometry system.

  3. Change in the number of TLESRs

    Time frame: The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.

    The investigators will measure the number of transient lower esophageal sphincter relaxations after a meal between placebo and citalopram, using a high resolution impedance manometry system.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.