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Barrett's Esophagus - 315 - 3 Way Cross-Over

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00637559
Collaborator
(none)
50
Enrollment
3
Arms
13
Duration (Months)

Study Details

Study Description

Brief Summary

This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.

Condition or Disease Intervention/Treatment Phase
  • Drug: Esomeprazole Magnesium
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Apr 1, 2003
Actual Study Completion Date :
Apr 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

40mg twice daily

Drug: Esomeprazole Magnesium
Other Names:
  • Nexium

    		•
    Experimental: 2

    40mg three times daily

    Drug: Esomeprazole Magnesium
    Other Names:
  • Nexium

    		•
    Experimental: 3

    20mg three times daily

    Drug: Esomeprazole Magnesium
    Other Names:
  • Nexium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily. [pH measured on Day 5]

    Secondary Outcome Measures

    1. Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period. [pH measured]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
    Exclusion Criteria:

    • A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.

    • History of various gastrointestinal diseases - please see investigator for full list.

    • Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.

    • Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Paula Fernstrom, Nexium Global Product Director, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00637559
    Other Study ID Numbers:
    • 315
    • D9612L00056
    First Posted:
    Mar 18, 2008
    Last Update Posted:
    Jan 25, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    Nexium
    Barrett's esophagus
    Additional relevant MeSH terms:
    Barrett Esophagus
    Esomeprazole

    Study Results

    No Results Posted as of Jan 25, 2011