A Phase Ⅲ Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Ilaprazole (20mg QD) in Adult Patients With Erosive Esophagitis
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Il-Yang Pharm. Co., Ltd.
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Overview
Brief Summary
This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D) within 14 days prior to baseline.
- •Episodes of heartburn or regurgitation has experienced during the last 7 days prior to baseline.
Exclusion Criteria
- •Coexisting diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. Presence of a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) or Barrett's esophagus were not exclusionary.
- •Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
- •Known hypersensitivity to any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of ilaprazole, or Gelusil.
- •Cancer (except basal cell carcinoma of the skin) within 5 years prior to screening.
Arms & Interventions
Ilaprazole
Ilaprazole 20mg
Intervention: Ilaprazole (Drug)
lansoprazole
lansoprazole 30mg
Intervention: Lansoprazole (Drug)
Outcomes
Primary Outcomes
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Time Frame: 8 Weeks
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Secondary Outcomes
- The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy(4 Weeks)