CClinicalTrials.gg
Status unknownNCT03499171Updated Dec 5, 2019

Citalopram for Reflux Hypersensitivity and Functional Heartburn

A Phase 4 interventional study of Citalopram 20mg and Placebo Oral Tablet in GERD, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 to 65 years old.
  2. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
  3. 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).
  4. 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.
  5. 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

Exclusion Criteria:

  1. Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
  2. Systemic diseases, known to affect esophageal motility.
  3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
  4. QT c>450 ms
  5. Treatment with SSRI's prior to the start of the study.
  6. Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics.
  7. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
  8. Major psychiatric disorder.
  9. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
  10. Pregnancy or breast feeding.
  11. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
  12. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Citalopram

    20mg, once a day

    Drug: Citalopram 20mg

  • Placebo comparator
    Placebo

    Once a day

    Drug: Placebo Oral Tablet

Interventions

  • DrugCitalopram 20mg

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

  • DrugPlacebo Oral Tablet

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

05

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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,

    Time frame: 8 weeks

  2. change in esophageal sensitivity

    change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03499171
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Prof Dr Jan Tack (Prof. Dr., Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Apr 17, 2018
Start date
May 27, 2019
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Dec 5, 2019

Study contacts

Hannelore Geysen
Contact
hannelore.geysen@kuleuven.be
+32 (0)16 324921

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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