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

NCT ID: NCT01103804

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

952 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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)

Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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CRISTINA TEODORESCU

Role: STUDY_DIRECTOR

AstraZeneca Pharma SRL Romania

Locations

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Research Site

Arad, , Romania

Site Status

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Bacau, , Romania

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Brasov, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Cluj-Napoca, , Romania

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Floreşti, , Romania

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Galati, , Romania

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Iași, , Romania

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Piteşti, , Romania

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Ploieşti, , Romania

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Rm. Valcea, , Romania

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Sibiu, , Romania

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Slatina, , Romania

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Târgovişte, , Romania

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Tg. Mures, , Romania

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Timișoara, , Romania

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Research Site

Vanatori(GL), , Romania

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Countries

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Romania

Other Identifiers

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NIS-GRO-DUM-2009/1

Identifier Type: -

Identifier Source: org_study_id

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