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An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Primary Purpose

GERD

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD focused on measuring Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
  2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.]
  3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

  1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
  2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
  3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
  4. Abnormal lab test results, as indicated in the protocol.
  5. Other diseases, as indicated in the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    20mg oral

    15 minute intravenous infusion

    Outcomes

    Primary Outcome Measures

    The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.

    Secondary Outcome Measures

    Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
    To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
    To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.

    Full Information

    First Posted
    February 27, 2008
    Last Updated
    January 24, 2011
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00629564
    Brief Title
    An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
    Official Title
    An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    October 2002 (Actual)
    Study Completion Date
    October 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    GERD
    Keywords
    Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    20mg oral
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    15 minute intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    20mg oral
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    15 minute intravenous infusion
    Primary Outcome Measure Information:
    Title
    The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
    Time Frame
    MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
    Secondary Outcome Measure Information:
    Title
    Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
    Time Frame
    BAO will be assessed after 10 days of treatment
    Title
    To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
    Time Frame
    Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
    Title
    To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.
    Time Frame
    Safety assessments throughout the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.] Able to communicate with the investigator and to understand and comply with the requirements of the study. Exclusion Criteria: History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease. Abnormal lab test results, as indicated in the protocol. Other diseases, as indicated in the protocol.

    12. IPD Sharing Statement

    Learn more about this trial

    An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

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