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Effect of Citalopram on Reflux Episodes in Healthy Volunteers

NCT03746691 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-11-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, Prof. · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746691 on ClinicalTrials.gov