Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erosive Esophagitis
Intervention: Esomeprazole (Drug); Lansoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
Summary
A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when
treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that
is in remission (i. e. previously healed EE).
Clinical Details
Official title: Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).
Secondary outcome: To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.The assessment of symptoms in the two treatment groups after 1, 3 and 6 months. To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Episodes of heartburn (described as a burning feeling rising from the stomach or lower
part of the chest up towards the neck) for 2 days or more during the last 7 days prior
to baseline
- Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before
entering the study.
Exclusion Criteria:
- Any signs of gastrointestinal bleeding at the time of the starting the study.
- Any previous gastric or esophageal surgery.
- Various gastrointestinal diseases as listed in the protocol.
Locations and Contacts
Additional Information
Starting date: December 2002
Ending date: March 2004
Last updated: March 21, 2008
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