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.
1 other identifier
observational
952
1 country
19
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 11, 2011
January 1, 2011
6 months
April 13, 2010
January 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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)
Eligibility Criteria
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)
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Arad, Romania
Research Site
Bacau, Romania
Research Site
Brasov, Romania
Research Site
Brăila, Romania
Research Site
Bucharest, Romania
Research Site
Buzău, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Floreşti, Romania
Research Site
Galati, Romania
Research Site
Iași, Romania
Research Site
Piteşti, Romania
Research Site
Ploieşti, Romania
Research Site
Rm. Valcea, Romania
Research Site
Sibiu, Romania
Research Site
Slatina, Romania
Research Site
Târgovişte, Romania
Research Site
Tg. Mures, Romania
Research Site
Timișoara, Romania
Research Site
Vanatori(GL), Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
CRISTINA TEODORESCU
AstraZeneca Pharma SRL Romania
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
January 11, 2011
Record last verified: 2011-01