Back to resultsMulticenter, 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
Primary Purpose
Erosive Esophagitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Lansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis focused on measuring Erosive Esophagitis, Nexium, Esomeprazole, Lansoprazole, Heartburn
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Nexium
Prevacid
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644735
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Erosive Esophagitis, Nexium, Esomeprazole, Lansoprazole, Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nexium
Arm Title
2
Arm Type
Active Comparator
Arm Description
Prevacid
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid
Primary Outcome Measure Information:
Title
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).
Time Frame
Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Secondary Outcome Measure Information:
Title
To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.
Time Frame
Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Title
The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.
Time Frame
patients will undergo an endoscopy at Months 3 and 6
Title
To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.
Time Frame
Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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