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NCT Number: NCT01130935

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

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.

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Key information

Conditions

Gastric Acid Suppression Deglutition Disorders Digestive System Diseases Duodenal Diseases Duodenal Ulcer Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Proton Pump Inhibitors Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Berat, Albania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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