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

Gastroesophageal Reflux Disease Clinical Trial

— Epi-ERGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094402
• Other study ID #: Epi-ERGE
• Status: Recruiting
• Start date: June 4, 2019
• Est. completion date: July 2024

Study information

• Verified date: September 2019
• Source: Scandinavia Pharma
• Contact: Javier Castillo, Dr
• Phone: +571-6461700
• Email: jcastill[@]scandinavia.com.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• None. It is an observational study
None. It is an observational study

Locations

Country	Name	City	State
Colombia	Scandinavia Pharma	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Scandinavia Pharma

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of GERD (Gastroesophageal Reflux Disease)	Proportion of patients with persistence and / or relapse of symptoms of GERD.	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	Demographic analysis	Characterization of patients	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	Kind of IBP taked by the patient and the way to consume it.	A descriptive analysis of the type of IBP types taken by patients and how to take them	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	Adverse Events related with the treatments	Evaluation of Adverse events associated with the treatment (s)	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