Clinical trial NCT01103804: Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: GerdQ questionnaire
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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)


Eligibility 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

Primary outcomes:
measure: describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ)
timeFrame: 4 weeks(at V1 and V2)
Secondary outcomes:
measure: measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ)
timeFrame: 4 weeks(at V1 and V2)
measure: identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ)
timeFrame: 4 weeks(at V1 and V2)
Other outcomes:
Locations:
city: Arad
country: Romania
facility: Research Site
city: Bacau
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Buzau
country: Romania
facility: Research Site
city: Cluj
country: Romania
facility: Research Site
city: Floresti
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Rm. Valcea
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Slatina
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Tg. Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Vanatori(GL)
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca Pharma SRL Romania
name: CRISTINA TEODORESCU
role: STUDY_DIRECTOR
References: