Effect of Citalopram on Reflux Episodes in Healthy Volunteers

NCT03746691 | Completed Phase 4

• 1 other identifier: S59148
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Citalopram, 20 mg, IV

EXPERIMENTAL

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

Placebo, IV

PLACEBO COMPARATOR

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

Interventions

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.

Citalopram, 20 mg, IV

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.

Placebo, IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jan Tack, Prof.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: November 20, 2018
• Study Start: February 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

BE (1)