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Trial record 14 of 226 for:    "Barrett syndrome"

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

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ClinicalTrials.gov Identifier: NCT00352261
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Drug: Esomeprazole Drug: Lansoprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352261


Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
United States, Illinois
Research Site
North Chicago, Illinois, United States
United States, Minnesota
Research Site
Rochester, Minnesota, United States
United States, Missouri
Research Site
Kansas City, Missouri, United States
Research SIte
Springfield, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
United States, Virginia
Research Site
Norfolk, Virginia, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Debra Silberg, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00352261     History of Changes
Other Study ID Numbers: D9612L00082
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Barrett's Esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esomeprazole
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action