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

Last updated: September 20, 2019
Sponsor: Scandinavia Pharma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT04094402
Epi-ERGE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Previous diagnosis of Gastroesophageal Reflux Disease (GERD)

  • CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment withsome PPI but YES in the last year

Exclusion

Exclusion Criteria:

  • Refusal to participate in the study by the patient.

  • Patients who, in the judgment of the Investigator, do not understand or are notwilling to adequately answer to the questions.

  • Mental or psychiatric illness that, in the judgment of the investigator, does notallow adequate information to be obtained.

Study Design

Total Participants: 1500
Study Start date:
June 04, 2019
Estimated Completion Date:
July 31, 2024

Study 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%.

Connect with a study center

  • Scandinavia Pharma

    Bogotá, 110111
    Colombia

    Active - Recruiting

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