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

Scandinavia Pharma

Status: Enrolling

Conditions: Gastroesophageal Reflux Disease

Treatments: Other: None. It is an observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT04094402

Epi-ERGE

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.