Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Scandinavia Pharma
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Symptoms of GERD (Gastroesophageal Reflux Disease)
- Last Updated
- 6 years ago
Overview
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%.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- 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)
- 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)