Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD) (Epi-ERGE)

September 20, 2019 updated by: Scandinavia Pharma

Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux

Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE: To carry out an evaluation about the persistence and / or relapse of symptoms in Colombian patients with diagnosis of GERD.

MATERIALS AND METHODS: A multicentric cross-sectional epidemiological study will be carried out in Colombian patients with diagnosis of GERD and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor). The persistence and / or relapse of symptoms will be evaluated as the main variable. The secondary variables to be evaluated include: Demographical analysis, treatment (s) used by patients, adverse events associated with the treatments, comorbidities and risk factors. The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
      • Bogotá, Colombia, 110111
        • Recruiting
        • Scandinavia Pharma
        • Contact:
          • Javier Castillo, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Previous diagnosis of Gastroesophageal Reflux Disease (GERD)
  • CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment with some PPI but YES in the last year

Exclusion Criteria:

  • Refusal to participate in the study by the patient.
  • Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
  • Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of GERD (Gastroesophageal Reflux Disease)
Time Frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Proportion of patients with persistence and / or relapse of symptoms of GERD.
It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic analysis
Time Frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Characterization of patients
It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Kind of IBP taked by the patient and the way to consume it.
Time Frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
A descriptive analysis of the type of IBP types taken by patients and how to take them
It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Adverse Events related with the treatments
Time Frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Evaluation of Adverse events associated with the treatment (s)
It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scandinavia Pharma

Investigators

  • Study Director: Javier Castillo, Dr, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epi-ERGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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