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NCT00352261 Clinical Trial

An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00352261
Other study ID # D9612L00082
Secondary ID
Status Completed
Phase Phase 4
First received July 12, 2006
Last updated March 25, 2009
Start date January 2006
Est. completion date April 2007

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole

• Lansoprazole

Locations
Country Name City State
United States Research Site Butte Montana
United States Research Site Cleveland Ohio
United States Research Site Dallas Texas
United States Research Site Kansas City Missouri
United States Research Site Knoxville Tennessee
United States Research Site Norfolk Virginia
United States Research Site North Chicago Illinois
United States Research Site Philadelphia Pennsylvania
United States Research Site Phoenix Arizona
United States Research Site Rochester Minnesota
United States Research SIte Springfield Missouri
United States Research Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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