Clinical trial NCT04094402: Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)
Official title: Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Scandinavia Pharma
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)

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%.

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.

Primary outcomes:
measure: Symptoms of GERD (Gastroesophageal Reflux Disease)
timeFrame: 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 outcomes:
measure: Demographic analysis
timeFrame: 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
measure: Kind of IBP taked by the patient and the way to consume it.
timeFrame: 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
measure: Adverse Events related with the treatments
timeFrame: 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
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Scandinavia Pharma
Study officials:
affiliation: Medical Director
name: Javier Castillo, Dr
role: STUDY_DIRECTOR
References: