NCT01200550

Brief Summary

The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

September 7, 2010

Last Update Submit

April 16, 2012

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux diseaseGERD Impact Scale

Outcome Measures

Primary Outcomes (4)

  • Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Maximum of 14 weeks, with 3 visits in total

  • Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Visit 1 (enrolment)

  • Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Visit 2 (4-6 weeks after Visit 1)

  • Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Visit 3 (8-14 weeks after Visit 1).

Secondary Outcomes (1)

  • The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients

    Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1).

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treted with proton pump inhibitors, for whom GP or specialist (in primary care unit) have previosly decided to initiate or change treatment for GERD.

You may qualify if:

  • Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice

You may not qualify if:

  • Females of childbearing potential should not be pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Research Site

Banja Luka, Bosnia and Herzegovina

Location

Research Site

Bijeljina, Bosnia and Herzegovina

Location

Research Site

Derventa, Bosnia and Herzegovina

Location

Research Site

Doboj, Bosnia and Herzegovina

Location

Research Site

Gračanica, Bosnia and Herzegovina

Location

Research Site

Gradačac, Bosnia and Herzegovina

Location

Research Site

Gradiška, Bosnia and Herzegovina

Location

Research Site

Hadžići, Bosnia and Herzegovina

Location

Research Site

Jelah, Bosnia and Herzegovina

Location

Research Site

Laktaši, Bosnia and Herzegovina

Location

Research Site

Lukavac, Bosnia and Herzegovina

Location

Research Site

Lukavica, Bosnia and Herzegovina

Location

Research Site

Matuzići, Bosnia and Herzegovina

Location

Research Site

Mostar, Bosnia and Herzegovina

Location

Research Site

Pale, Bosnia and Herzegovina

Location

Research Site

Prijedor, Bosnia and Herzegovina

Location

Research Site

Sarajevo, Bosnia and Herzegovina

Location

Research Site

Trn, Bosnia and Herzegovina

Location

Research Site

Tuzla, Bosnia and Herzegovina

Location

Research Site

Visoko, Bosnia and Herzegovina

Location

Research Site

Vogošća, Bosnia and Herzegovina

Location

Research Site

Zalužani, Bosnia and Herzegovina

Location

Research Site

Živinice, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Srdjan Gornjakovic, MD, PhD

    Clinical Center University of Sarajevo; Department of Gastrenterology and HepatologySarajevo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 13, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

BO(23)