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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103804
First Posted: April 15, 2010
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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)

Condition
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]

Enrollment: 952
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103804


Locations
Romania
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: CRISTINA TEODORESCU AstraZeneca Pharma SRL Romania
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103804     History of Changes
Other Study ID Numbers: NIS-GRO-DUM-2009/1
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: January 11, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
GerdQ questionnaire

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action