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Citalopram for Reflux Hypersensitivity and Functional Heartburn

Primary Purpose

GERD

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Citalopram 20mg

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 to 65 years old.
History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
Systemic diseases, known to affect esophageal motility.
Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
QT c>450 ms
Treatment with SSRI's prior to the start of the study.
Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics.
Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
Major psychiatric disorder.
Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
Pregnancy or breast feeding.
History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Sites / Locations

UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citalopram

Placebo

Arm Description

20mg, once a day

Once a day

Outcomes

Primary Outcome Measures

change in number of reflux episodes

The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.

Secondary Outcome Measures

change in reflux parameters

change in reflux parameters (number of reflux episodes with a high proximal extent, volume exposure) assessed by 24 hour impedance-pH monitoring,

change in esophageal sensitivity

change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure

change in symptom severity

change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries). Patients will have to indicate the symptom occurence and symptom severity on a scale. Two words, on each site of the scale indicate their symptom severity (on the left "totally not present" on the right "very strong present"). A higher score represents a worse outcome.

Full Information

NCT ID

NCT03499171

First Posted

April 11, 2018

Last Updated

December 4, 2019

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03499171

Brief Title

Citalopram for Reflux Hypersensitivity and Functional Heartburn

Official Title

A Placebo-controlled Trial With Citalopram for the Treatment of Typical Reflux Symptoms in Patients With Reflux Hypersensitivity or Functional Heartburn With Incomplete Proton Pump Inhibitor Response

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 27, 2019 (Actual)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Citalopram is a drug used in the treatment of depressive episodes and belongs to the group of selective serotonin reuptake inhibitors (SSRI). Serotonin is an important neurotransmitter predominantly found in the brain and the gastrointestinal tract. Serotonin is associated with psychological disorders, including anxiety and depression, and emotion regulation and it has been shown that anxiety and depression are associated with increased severity of GERD-related symptoms. Citalopram and other SSRI's elevate the concentration of serotonin by blocking the reabsorption into the presynaptic neuron and thereby increasing the level of serotonin available to bind the postsynaptic receptor. A recent study showed beneficial effects of citalopram in patients with reflux hypersensitivity. However, there was no objective measurement for reflux nor esophageal sensitivity during the treatment period. Moreover, the effect of citalopram in patients with functional heartburn has not been studied so far. Therefore, the inevestigators will conduct a randomized, parallel, placebo-controlled study to evaluate the efficacy of citalopram on the improvement in symptom severity, reflux parameters and esophageal sensitivity. 50 patients with reflux hypersensitivity and 50 patients with functional heartburn will receive either placebo or citalopram (Cipramil®) 20 mg as an add-on for a period of 8 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries), reflux parameters by performing a 24 hour impedance-pH monitoring and esophageal sensitivity using the multimodal esophageal stimulation paradigm

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GERD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Citalopram

Arm Type

Experimental

Arm Description

20mg, once a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Once a day

Intervention Type

Drug

Intervention Name(s)

Citalopram 20mg

Intervention Description

Citalopram is taken once a day as an add-on to PPI treatment (2x/d).

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Placebo is taken once a day as an add-on to PPI treatment (2x/d)

Primary Outcome Measure Information:

Title

change in number of reflux episodes

Description

The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

change in reflux parameters

Description

change in reflux parameters (number of reflux episodes with a high proximal extent, volume exposure) assessed by 24 hour impedance-pH monitoring,

Time Frame

8 weeks

Title

change in esophageal sensitivity

Description

change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure

Time Frame

8 weeks

Title

change in symptom severity

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 65 years old. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent). Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. Exclusion Criteria: Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening. Systemic diseases, known to affect esophageal motility. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed). QT c>450 ms Treatment with SSRI's prior to the start of the study. Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. Major psychiatric disorder. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening. Pregnancy or breast feeding. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hannelore Geysen

Phone

+32 (0)16 324921

hannelore.geysen@kuleuven.be

Facility Information:

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hannelore Geysen

Phone

+32 (0)16 324921

hannelore.geysen@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Citalopram for Reflux Hypersensitivity and Functional Heartburn

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