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: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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

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
    

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
    
• 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
    
• 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
    

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

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