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Citalopram for Reflux Hypersensitivity and Functional Heartburn

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ClinicalTrials.gov Identifier: NCT03499171
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE May 27, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
change in number of reflux episodes [ Time Frame: 8 weeks ]
The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
change in number of reflux episodes [ Time Frame: 8w ]
The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • change in reflux parameters [ Time Frame: 8 weeks ]
    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 [ Time Frame: 8 weeks ]
    change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure
  • change in symptom severity [ Time Frame: 8 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • change in reflux parameters [ Time Frame: 8w ]
    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 [ Time Frame: 8w ]
    change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure
  • change in symptom severity [ Time Frame: 8w ]
    change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Citalopram for Reflux Hypersensitivity and Functional Heartburn
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE
  • Drug: Citalopram 20mg
    Citalopram is taken once a day as an add-on to PPI treatment (2x/d).
  • Drug: Placebo Oral Tablet
    Placebo is taken once a day as an add-on to PPI treatment (2x/d)
Study Arms  ICMJE
  • Experimental: Citalopram
    20mg, once a day
    Intervention: Drug: Citalopram 20mg
  • Placebo Comparator: Placebo
    Once a day
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hannelore Geysen +32 (0)16 324921 hannelore.geysen@kuleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499171
Other Study ID Numbers  ICMJE S61111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP