An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
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
1 other identifier
interventional
80
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 12, 2006
CompletedFirst Posted
Study publicly available on registry
July 14, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 26, 2009
March 1, 2009
July 12, 2006
March 25, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Documented history (within 2 yrs of histologically proven BE;
- Aged 18-70 (inclusive);
- Willing and able to comply with all study procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Debra Silberg, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2006
First Posted
July 14, 2006
Study Start
January 1, 2006
Study Completion
April 1, 2007
Last Updated
March 26, 2009
Record last verified: 2009-03