PPI's and SSRI's Therapy for the Management of NCCP (NCCP)
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|ClinicalTrials.gov Identifier: NCT02825342|
Recruitment Status : Terminated (Primary endpoint was reached.)
First Posted : July 7, 2016
Last Update Posted : December 2, 2019
Non cardiac chest pain (NCCP) is defined as recurring, angina-like, retrosternal chest pain of non cardiac origin. Annual prevalence of NCCP in the general population of the western world ranges from 25-35%. Of those patients presenting to an emergency room with chest pain, a cardiac etiology is ultimately found in only 11-39%. Several conditions are associated with NCCP, with gastroesophageal reflux disease (GERD) being the most prevalent, constituting up to 60% of cases. However, NCCP is considered a disorder of heterogenous nature and several other conditions, apart of GERD, such as esophageal dysmotility and esophageal hypersensitivity have been implicated.
Treatment of NCCP remains a real challenge due to the diverse underlying mechanisms responsible for patients' symptoms. Given the fact that GERD is by far the most common etiology, proton pump inhibitor (PPI) therapy has been tried extensively; however, after 6 weeks of treatment complete resolution of symptoms occurs in only 30% of patients, the optimal duration of PPI administration is not known, while the best maintenance dose has never been determined. Although the administration of selective serotonin reuptake inhibitors (SSRIs) could theoretically benefit those patients with esophageal hypersensitivity, the trials that have been published so far have included small number of patients and reported conflicting results, while the co-administration of PPIs with SSRIs has not been evaluated so far. Furthermore, data on treatment of patients with functional chest pain are lacking.
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Rule Out Myocardial Infarction||Drug: Citalopram||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Pump Inhibitor (PPI's) and Selective Serotonin Reuptake Inhibitor Therapy (SSRI's) for the Management of Non Cardiac Chest Pain (NCCP)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||December 2017|
No Intervention: GERD with PPI's therapy
Patients will abnormal distal acid esophageal exposure will receive PPI twice daily for 8 weeks .
Active Comparator: PPI's and SSRI's therapy
Patients with positive symptom index for chest pain will receive citalopram 20 mg once daily and PPI once daily for 8 weeks.
Other Name: Proton Pump Inhibitor
Active Comparator: SSRI's therapy
Patients with a negative symptom index for chest pain will receive citalopram 20mg once daily for 8 weeks
Other Name: Proton Pump Inhibitor
- complete disappearance of the chest pain [ Time Frame: at the end of the 8-week period of therapy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825342
|Athens, Attiki, Greece, 10676|