PPI's and SSRI's Therapy for the Management of NCCP

NCT02825342 | Terminated Phase 4

• 1 other identifier: EvangelismosH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain Rule Out Myocardial Infarction

Keywords

Gastroesophageal Reflux Disease (GERD); Proton Pump Inhibitor (PPI)

Outcome Measures

Primary Outcomes (1)

• complete disappearance of the chest pain

  at the end of the 8-week period of therapy.

Study Arms (3)

GERD with PPI's therapy

NO INTERVENTION

Patients will abnormal distal acid esophageal exposure will receive PPI twice daily for 8 weeks .

PPI's and SSRI's therapy

ACTIVE COMPARATOR

Patients with positive symptom index for chest pain will receive citalopram 20 mg once daily and PPI once daily for 8 weeks.

Drug: Citalopram

SSRI's therapy

ACTIVE COMPARATOR

Patients with a negative symptom index for chest pain will receive citalopram 20mg once daily for 8 weeks

Drug: Citalopram

Interventions

Citalopram DRUG

Also known as: Proton Pump Inhibitor

PPI's and SSRI's therapy; SSRI's therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Citalopram; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 7, 2016
• Study Start: March 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)