An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Barrett's Esophagus
Intervention: Esomeprazole (Drug); Lansoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Debra Silberg, MD, Study Director, Affiliation: AstraZeneca
Summary
The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and
lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients
Clinical Details
Official title: An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients by evaluation of the percentage of time that intragastric pH is >4.0 over a 24 hr period steady state
Secondary outcome: Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg bid in controlling intragastric pH in BE patients by evaluation of the % of time intragastric pH is >4.0 over 24 hr period at steady state
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Documented history (within 2 yrs of histologically proven BE;
- Aged 18-70 (inclusive);
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Signs of clinically significant GI bleeding within 3 days prior to randomization;
- History of gastric or esophageal surgery;
- Clinically significant illness within 2 weeks prior to first dose of study drug or
during study
Locations and Contacts
Research Site, Phoenix, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, North Chicago, Illinois, United States
Research Site, Rochester, Minnesota, United States
Research Site, Kansas City, Missouri, United States
Research SIte, Springfield, Missouri, United States
Research Site, Butte, Montana, United States
Research Site, Cleveland, Ohio, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Norfolk, Virginia, United States
Additional Information
Starting date: January 2006
Last updated: June 19, 2007
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