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

January 10, 2011 updated by: AstraZeneca

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.

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)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

952

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Arad, Romania
        • Research Site
      • Bacau, Romania
        • Research Site
      • Braila, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Buzau, Romania
        • Research Site
      • Cluj, Romania
        • Research Site
      • Floresti, Romania
        • Research Site
      • Galati, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Pitesti, Romania
        • Research Site
      • Ploiesti, Romania
        • Research Site
      • Rm. Valcea, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
      • Slatina, Romania
        • Research Site
      • Targoviste, Romania
        • Research Site
      • Tg. Mures, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
      • Vanatori(GL), Romania
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population are patients known/newly diagnosed with GERD or with symptoms suggesting GERD( hearburn, regurgitations) who presented to their family physician(primary care clinic)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ)
Time Frame: 4 weeks(at V1 and V2)
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)
Time Frame: 4 weeks(at V1 and V2)
4 weeks(at V1 and V2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: CRISTINA TEODORESCU, AstraZeneca PHARMA SRL ROMANIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GRO-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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