GERD Clinical Trial
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
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06084572 -
Prospective Evaluation of pH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
|
||
| Completed |
NCT03568825 -
Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose
|
N/A | |
| Recruiting |
NCT04703374 -
A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04120025 -
Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients
|
N/A | |
| Withdrawn |
NCT04771247 -
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT02575287 -
Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes
|
N/A | |
| Completed |
NCT01710800 -
Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy
|
N/A | |
| Completed |
NCT00287339 -
The Utility of Nexium in Chronic Cough and Reflux Disease
|
Phase 4 | |
| Completed |
NCT00287391 -
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
|
Phase 4 | |
| Completed |
NCT00629564 -
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
|
Phase 4 | |
| Completed |
NCT04243668 -
ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
|
N/A | |
| Completed |
NCT03558477 -
PK/PD Clinical Trial of YYD601 in Healthy Adult Male
|
Phase 1 | |
| Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
| Completed |
NCT05069493 -
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
|
||
| Completed |
NCT03238534 -
Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS
|
Phase 4 | |
| Recruiting |
NCT05974722 -
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
|
N/A | |
| Recruiting |
NCT05781347 -
Stretta Versus Conservative Treatment in Obese and Non-obese
|
N/A | |
| Completed |
NCT06141577 -
A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT05108038 -
A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT02587910 -
Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 |