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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01103804
First received: April 13, 2010
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  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.

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01103804     History of Changes
Other Study ID Numbers: NIS-GRO-DUM-2009/1
Study First Received: April 13, 2010
Last Updated: January 10, 2011
Health Authority: Romania: National Medicines Agency

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013