Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

NCT ID: NCT01130935

Last Updated: 2011-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

491 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.

Detailed Description

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Conditions

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Gastric Acid Suppression Proton Pump Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject must have had upper GI symptoms requiring acid suppression treatment
* Treatment with Nexium is in accordance with indications and dosing approved in Albania.
* Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.

Exclusion Criteria

* Known hypersensitivity to Nexium or any other constituents of the formulation
* Concomitant administration of atazanavir and nelfinavir.
* Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Albania

Principal Investigators

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Karin Otter, MD, PhD

Role: STUDY_DIRECTOR

Medical Director BBC

Senka Riza

Role: STUDY_CHAIR

Medical and Regulatory Manager

Skerdi Prifti, Asc.Proff.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center "Mother Teresa"

Locations

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Research Site

Berat, , Albania

Site Status

Research Site

Burrel, , Albania

Site Status

Research Site

Durrës, , Albania

Site Status

Research Site

Elbasan, , Albania

Site Status

Research Site

Fier, , Albania

Site Status

Research Site

Kavajë, , Albania

Site Status

Research Site

Korçë, , Albania

Site Status

Research Site

Krujë, , Albania

Site Status

Research Site

Lezhë, , Albania

Site Status

Research Site

Lushnjë, , Albania

Site Status

Research Site

Peshkopi, , Albania

Site Status

Research Site

Shkodër, , Albania

Site Status

Research Site

Tirana, , Albania

Site Status

Research Site

Vlorë, , Albania

Site Status

Countries

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Albania

Other Identifiers

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NIS-GAL-NEX-2010/1

Identifier Type: -

Identifier Source: org_study_id

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