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

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.

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Drug: Citalopram HCl; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citalopram, 20 mg, IV; After placement of a high resolution impedance manometry catheter (transnasally), citalopram will be administered IV over 30 minutes (20 mg in 100ml saline). Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours.	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.
Placebo Comparator: Placebo, IV; After placement of a high resolution impedance manometry catheter (transnasally), placebo (saline 100ml) will be administered IV over 30 minutes. Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jan Tack, Prof., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: S59148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No