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.”

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

Study Type: Interventional

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

Study Primary Completion Date: August 2003

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 40mg once daily
• Drug: Lansoprazole
  • 30mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nexium
• Active Comparator: 2
  • Prevacid

Primary Measures

• 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.
  • Time Frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
    

Secondary Measures

• 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.
  • Time Frame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
    
• 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.
  • Time Frame: Dairy card to be completed by patient daily
    
• To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.
  • Time Frame: Adverse event collection on an ongoing basis
    

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.

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641602

Study ID Number: 322

ClinicalTrials.gov Identifier: NCT00641602

Health Authority: United States: Food and Drug Administration