A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
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
This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated
with either esomeprazole or lansoprazole
Clinical Details
Official title: A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
Secondary outcome: 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary. To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe 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 Erosive Esophagitis within 1 week prior to starting 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: October 2003
Last updated: March 21, 2008
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