Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Study Overview
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Brief Summary
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This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.

Official Title
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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

Conditions
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Erosive Esophagitis, GERD

Intervention / Treatment
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* Drug: Ilaprazole
* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole<br>Ilaprazole 20mg | Drug: Ilaprazole<br>* 20mg/Tap, QD<br>* Other names: Noltec;|
| Active Comparator: lansoprazole<br>lansoprazole 30mg | Drug: Lansoprazole<br>* 30mg/Tap, QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy | 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). | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy |  | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive Esophagitis, Ilaprazole, GERD