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

Erosive Esophagitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644735
• Other study ID #: 325
• Secondary ID: D9612L00048
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 25, 2009
• Start date: December 2002
• Est. completion date: January 2004

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• 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 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.

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

• Lansoprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Secondary	To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.		Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Secondary	The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.		patients will undergo an endoscopy at Months 3 and 6
Secondary	To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.		Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6