Reflux Esophagitis Phase III Study (Initial Treatment)

Phase 3

Completed

• Conditions: Reflux Esophagitis
• Interventions: Drug: Esomeprazole; Drug: Omeprazole

• Registration Number: NCT00633932
• Lead Sponsor: AstraZeneca

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-10
• Results First Submitted QC: 2010-03-26
• Results First Posted: 2010-04-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Esomeprazole	Esomeprazole 40mg
3	Omeprazole	Omeprazole 20mg
1	Esomeprazole	Esomeprazole 20mg

Primary Outcome Measures

Name	Time	Method
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".	8 weeks	Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification	4 weeks	Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tottori, Japan