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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 : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
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.
Drug: Citalopram
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
Drug: Citalopram
Other Name: Proton Pump Inhibitor




Primary Outcome Measures :
  1. complete disappearance of the chest pain [ Time Frame: at the end of the 8-week period of therapy ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients should have at least 3 episodes of chest pain per week in the previous 3 months. Meanwhile they should have undergone a comprehensive diagnostic evaluation by cardiologists in order to exclude a cardiac source for their chest pain. Patients recruited in the study should have either a normal coronary angiogram or lack of ischemic heart disease on exercise treadmill or stress thallium testing.

Exclusion Criteria:

The exclusion criteria will be: i) a history of thoracic, esophageal or gastric surgery, ii) primary or secondary esophageal motility disorders, iii) use of non-steroidal anti-inflammatory drugs and aspirin, iv) presence of Barrett's esophagus, erosive esophagitis, peptic stricture and duodenal or gastric ulcer on upper endoscopy, v) eosinophilic esophagitis, vi) underlying psychiatric illness, vii) pregnancy in women, viii) refusal to participate.


Information from the National Library of Medicine

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


Locations
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Greece
Evangelismos Hospital
Athens, Greece, 10676
Sponsors and Collaborators
Evangelismos Hospital

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Responsible Party: Nikos Viazis, Director, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT02825342     History of Changes
Other Study ID Numbers: EvangelismosH
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nikos Viazis, Evangelismos Hospital:
Gastroesophageal Reflux Disease (GERD)
Proton Pump Inhibitor (PPI)

Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Myocardial Infarction
Infarction
Chest Pain
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics