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

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT04094402
• Lead Sponsor: Scandinavia Pharma

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-04
• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of GERD (Gastroesophageal Reflux Disease)	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.

Secondary Outcome Measures

Name	Time	Method
Demographic analysis	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
Kind of IBP taked by the patient and the way to consume it.	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
Adverse Events related with the treatments	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)

Trial Locations

Locations (1)

Scandinavia Pharma; 🇨🇴 Bogotá, Colombia