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

Erosive Esophagitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641602
• Other study ID #: 322
• Secondary ID: D9612L00046
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 25, 2009
• Start date: December 2002
• Est. completion date: August 2003

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

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