Citalopram for Reflux Hypersensitivity and Functional Heartburn

NCT03499171 | Unknown Phase 4

• 1 other identifier: S61111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (3)

• change in reflux parameters

  8 weeks

• change in esophageal sensitivity

  8 weeks

• change in symptom severity

  8 weeks

Study Arms (2)

Citalopram

EXPERIMENTAL

20mg, once a day

Drug: Citalopram 20mg

Placebo

PLACEBO COMPARATOR

Once a day

Drug: Placebo Oral Tablet

Interventions

Citalopram 20mg DRUG

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

Citalopram

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old.
• History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Citalopram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hannelore Geysen

CONTACT

+32 (0)16 324921; hannelore.geysen@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 17, 2018
• Study Start: May 27, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)