Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746691
• Other study ID #: S59148
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LES pressure	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).	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.
Primary	Change in the 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.	The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.
Primary	Change in the 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.	The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.