Reflux Esophagitis Phase III Study (Initial Treatment)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Reflux Esophagitis

Treatments: Drug: Omeprazole; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633932

D961HC00002

Details and patient eligibility

About

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Enrollment: 602 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

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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602 participants in 3 patient groups

1

Experimental group

Description:

Esomeprazole 20mg

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

2

Experimental group

Description:

Esomeprazole 40mg

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

3

Active Comparator group

Description:

Omeprazole 20mg

Treatment:

Drug: Omeprazole