NCT00914342

Brief Summary

The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
889

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

54 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

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

First QC Date

June 3, 2009

Last Update Submit

December 24, 2009

Conditions

Keywords

GerdGerdQ questionnairework productivityGreece

Outcome Measures

Primary Outcomes (1)

  • GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).

    Single Visit - once

Secondary Outcomes (3)

  • Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ)

    Single Visit - Once

  • Describe the impact of GERD symptoms on work productivity.

    Single Visit - Once

  • To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.

    Single Visit - Once

Study Arms (1)

Upper-GI symptoms in primary-care patients

Eligibility Criteria

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

Patients who consult their primary care physician and have experienced upper-GI symptoms during the last week prior their consultation

You may qualify if:

  • Patients with upper-GI symptoms the last week prior visiting the investigator

You may not qualify if:

  • History of oesophageal, gastric or duodenal surgery
  • Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
  • PPI use for healing of NSAIDs induced ulcer or for HP eradication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (54)

Research Site

Pátrai, Achaias, Greece

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Mesologgion, Aitoloakarnaniaia, Greece

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Naupaktos, Aitoloakarnaniaia, Greece

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Grinion, Aitoloakarnania, Greece

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Aleksandroupoli, Aleksandroupoli, Greece

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Tripoli, Arkadias, Greece

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Acharnes, Attica, Greece

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Ag.Eleutherios, Attica, Greece

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Ag.Paraskeui, Attica, Greece

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Artémida, Attica, Greece

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Athens, Attica, Greece

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Chalandri, Attica, Greece

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Galatsi, Attica, Greece

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Glifada, Attica, Greece

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Ilipoli, Attica, Greece

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Kallithea, Attica, Greece

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Keratea, Attica, Greece

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Marousi, Attica, Greece

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N Makri, Attica, Greece

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N Smirni, Attica, Greece

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N.Herakeleios, Attica, Greece

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Peristeri, Attica, Greece

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Pikermi, Attica, Greece

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Pikerni, Attica, Greece

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Spata, Attica, Greece

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Chalcis, Chalkida, Greece

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Chalkidiki, Chalkidiki, Greece

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Chania, Chania, Greece

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Corinth, Corinth, Greece

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Mykonos, Cyclades, Greece

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Santorini, Cyclades, Greece

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Drama, Drama, Greece

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Zakynthos, Eptanisa, Greece

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Lamia, Ftiotida, Greece

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Heraklion, Herakleion, Greece

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Lexena, Ilias, Greece

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Véroia, Imathias, Greece

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Ioannina, Ioannina, Greece

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Karditsa, Karditsa, Greece

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Kastoria, Kastoria, Greece

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Katerini, Katerini, Greece

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Chrisoupoli, Kavala, Greece

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Komotini, Komotini, Greece

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Lakonia, Lakonia, Greece

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Larrisa, Larrisa, Greece

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Volos, Magnisia, Greece

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Kalamata, Mesinia, Greece

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Giannitsá, Pella, Greece

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Pereus, Pereus, Greece

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Ptolemaida, Ptolemaida, Greece

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Thessaloniki, Salonika, Greece

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Serres, Serres, Greece

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Trikala, Trikala, Greece

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Xánthi, Xanthi, Greece

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MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Theodoros Rokkas, Dr

    Henry Dynan Hospital, Athens, Greece

    PRINCIPAL INVESTIGATOR
  • Panagiotis Pontikis, Dr

    AstraZeneca Greece

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

July 1, 2009

Study Completion

December 1, 2009

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations