Gastroesophageal Reflux Disease
Conditions
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%.
Interventions
OTHERNone. It is an observational study
None. It is an observational study
Sponsors
Scandinavia Pharma
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Colombia
Contacts
Primary ContactJavier Castillo, Dr
Backup ContactFerrari Claudio, Dr
Outcome results
None listed