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
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)...
Brief Summary
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.”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: January 2004
Intervention(s) in this Clinical Trial
- Drug: Esomeprazole
- Drug: Lansoprazole
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Nexium
- Active Comparator: 2
- Prevacid
Outcome Measures for this Clinical Trial
Primary 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).
- Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
- 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 Measures
- 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
- Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
- 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
- Time Frame: patients will undergo an endoscopy at Months 3 and 6
- 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
- Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644735
Study ID Number: 325
ClinicalTrials.gov Identifier: NCT00644735
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00644735
