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

A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01130935

Enrollment

491

Registered

2010-05-26

Start date

2010-05-31

Completion date

2010-11-30

Last updated

2011-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Acid Suppression, Proton Pump Inhibitors

Keywords

GERD, gastric and duodenal ulcers, NSAID therapy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.	Day 0

Secondary

Measure	Time frame
To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.	Day 0
Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.	Once: Day 0
Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.	Day 0

Countries

Albania

Outcome results