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Completed

NCT Number: NCT01103804

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

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)

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arad, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 15, 2010
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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