Back to resultsAn Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Primary Purpose
Barrett's Esophagus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
Lansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's Esophagus
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SIte
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00352261
Brief Title
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's Esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Silberg, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Research SIte
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
We'll reach out to this number within 24 hrs