Reflux Esophagitis Phase III Study (Maintenance Treatment)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Reflux Esophagitis

Treatments: Drug: Esomeprazole; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634114

D961HC00006

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.

Enrollment: 540 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002)
• Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI

Exclusion criteria

• Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
• Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 2 patient groups

1

Experimental group

Description:

Esomeprazole and Omeprazole

Treatment:

Drug: Esomeprazole

Drug: Omeprazole

Drug: Esomeprazole

2

Experimental group

Description:

Esomeprazole

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole