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CompletedNCT01134367Updated Jul 14, 2011

An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease

An observational study in GERD, sponsored by AstraZeneca. Completed at 7 sites in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-14.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.

02

Conditions studied

  • GERD

Keywords

  • gastroesophageal reflux disease (GERD)
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

primary care clinics

Eligibility criteria

Inclusion Criteria:

  • Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre
  • Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)
05

Study design

Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 1

    Patients with GERD

06

What researchers measure

Primary outcomes

  1. Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Typical GERD symptoms (indicating frequency and severity of symptoms) and signs

    Time frame: 8 weeks

  2. Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data

    Time frame: 8 weeks

  3. Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Treatments for GERD and treatment changes

    Time frame: 8 weeks

  4. Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Patient's perspective of symptom control and impact on daily life assessed using a patient-questionnaire (GIS-GERD Impact Scale).

    Time frame: 8 weeks

Secondary outcomes

  1. To evaluate the added value of a patient questionnaire (GIS-GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment

    Time frame: 8 weeks

07

Study locations

7 sites
  • Research Site
    Belgrade, Serbia
  • Research Site
    Leskovac, Serbia
  • Research Site
    Nis, Serbia
  • Research Site
    Novi Sad, Serbia
  • Research Site
    Pancevo, Serbia
  • Research Site
    Subotica, Serbia
  • Research Site
    Zrenjanin, Serbia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01134367
Lead sponsor
AstraZeneca
First posted
Jun 2, 2010
Start date
May 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 14, 2011

Study contacts

Miodrag Krstić, Prof.Dr
principal investigator · Institute for Gastroenterology, Clinical Center of Serbia, Belgrade
Dragomir Damjanov, Prof. Dr
principal investigator · Clinic for Internal Diseases, Clinical Center of Vojvodina, Novi Sad
Aleksandar Nagorni, Prof. Dr
principal investigator · Clinic for Internal Diseases- Gastroenterology Dept, Clinical Center Nis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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