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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01130935
First received: May 20, 2010
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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
Gastric Acid Suppression
Proton Pump Inhibitors

Study Type: Observational
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Week 2-4 ] [ Designated as safety issue: No ]
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 2-4 ] [ Designated as safety issue: No ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 2-4 ] [ Designated as safety issue: No ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]

Enrollment: 491
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130935

Locations
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
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"
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca Albania
ClinicalTrials.gov Identifier: NCT01130935     History of Changes
Other Study ID Numbers: NIS-GAL-NEX-2010/1
Study First Received: May 20, 2010
Last Updated: February 23, 2011
Health Authority: Albania: Ministry of Health Department of Pharmacy

Keywords provided by AstraZeneca:
GERD
gastric and duodenal ulcers
NSAID therapy

ClinicalTrials.gov processed this record on April 17, 2014