Phase 3 N=572 Randomized Quadruple-blind Treatment

Reflux Esophagitis Phase III Study (Initial Treatment)

Reflux Esophagitis

Bottom Line

View on ClinicalTrials.gov: NCT00633932 ↗

Enrolled (actual)

572

Serious AEs

0.4%

Results posted

Apr 2010

Primary outcome: Primary: 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". — 171; 165; 166 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Esomeprazole (Drug); Omeprazole (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY 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".	171; 165; 166	—
SECONDARY 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	141; 147; 143	—

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 .

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00633932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.