Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment

A Prospective, Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Systematic Treatment With PPIs in GERD Patients in Primary Care Setting in Romania, Using the Validated GerdQ Questionnaire.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01103804

Enrollment

952

Registered

2010-04-15

Start date

2010-03-31

Completion date

2010-09-30

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

GerdQ questionnaire

Brief summary

The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Provision of informed consent * Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be ≥8, in the absence of PPI treatment)

Exclusion criteria

* Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia. * Previous participation in the present study

Design outcomes

Primary

Measure	Time frame
describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ)	4 weeks(at V1 and V2)

Secondary

Measure	Time frame
measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ)	4 weeks(at V1 and V2)
identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ)	4 weeks(at V1 and V2)

Countries

Romania

Outcome results