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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

Tracking Information
First Submitted Date May 20, 2010
First Posted Date May 26, 2010
Last Update Posted Date February 24, 2011
Study Start Date May 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2010)
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Day 0 ]
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Week 2-4 ]
  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Weeks 8-12 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01130935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 28, 2010)
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: 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. [ Time Frame: Once: Day 0 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Day 0 ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 2-4 ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 8-12 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 2-4 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 8-12 ]
Original Secondary Outcome Measures
 (submitted: May 25, 2010)
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: 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. [ Time Frame: Once: Day 0 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms [ Time Frame: Day 0 ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 2-4 ]
  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 8-12 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms [ Time Frame: Weeks 2-4 ]
  • Evaluate the tolerability of Nexium in patients with upper GI symptoms [ Time Frame: Weeks 8-12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
Official Title A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.
Condition
  • Gastric Acid Suppression
  • Proton Pump Inhibitors
Intervention Not Provided
Study Groups/Cohorts 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 23, 2011)
491
Original Estimated Enrollment
 (submitted: May 25, 2010)
400
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Albania
Removed Location Countries  
 
Administrative Information
NCT Number NCT01130935
Other Study ID Numbers NIS-GAL-NEX-2010/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MC MD, AstraZeneca Albania
Study Sponsor AstraZeneca
Collaborators Not Provided
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"
PRS Account AstraZeneca
Verification Date February 2011