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Trial record 6 of 31 for:    ( Map: Albania )

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

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ClinicalTrials.gov Identifier: NCT01130935
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
Gastric Acid Suppression Proton Pump Inhibitors

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Study Type : Observational
Actual Enrollment : 491 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Group/Cohort
1



Primary Outcome Measures :
  1. Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Day 0 ]
  2. Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Week 2-4 ]
  3. Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Weeks 8-12 ]

Secondary Outcome Measures :
  1. To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Day 0 ]
  2. Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania. [ Time Frame: Once: Day 0 ]
  3. Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Day 0 ]
  4. To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 2-4 ]
  5. To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 8-12 ]
  6. Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 2-4 ]
  7. Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 8-12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130935


Locations
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Albania
Research Site
Berat, Albania
Research Site
Burrel, Albania
Research Site
Durres, Albania
Research Site
Elbasan, Albania
Research Site
Fier, Albania
Research Site
Kavaje, Albania
Research Site
Korce, Albania
Research Site
Kruje, Albania
Research Site
Lezhe, Albania
Research Site
Lushnje, Albania
Research Site
Peshkopi, Albania
Research Site
Shkoder, Albania
Research Site
Tirane, Albania
Research Site
Vlore, Albania
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Karin Otter, MD, PhD Medical Director BBC
Study Chair: Senka Riza Medical and Regulatory Manager
Principal Investigator: Skerdi Prifti, Asc.Proff. University Hospital Center "Mother Teresa"

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Responsible Party: MC MD, AstraZeneca Albania
ClinicalTrials.gov Identifier: NCT01130935     History of Changes
Other Study ID Numbers: NIS-GAL-NEX-2010/1
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011
Keywords provided by AstraZeneca:
GERD
gastric and duodenal ulcers
NSAID therapy
Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action