Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Detailed Description
-----------------
This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.

Official Title
-----------------
A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.

Conditions
-----------------
Esophagitis

Intervention / Treatment
-----------------
* Drug: Ilaprazole
* Drug: Ilaprazole
* Drug: Ilaprazole
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condition likely to require surgery; cancer within 5 years of screening; or abnormal laboratory values. Co-existing diseases affecting the esophagus; history of esophageal radiation therapy, cryotherapy, or physiochemical trauma. History of esophageal surgery or dilatation of an esophageal stricture other than Schatzki's ring; gastric or duodenal surgery except simple oversew of an ulcer. Active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening. Current or history of Zollinger-Ellison syndrome or other hypersecretory conditions. Allergy to any proton pump inhibitor drug (omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole), any component of Ilaprazole, or antacid. Unable to tolerate lactose. Use of the following medications prior to randomization or anticipated use during the study: proton pump inhibitors, antacids, biphosphonates, histamine (H2) receptor antagonist (examples: Zantac, Tagamet), sucralfate, misoprostol, corticosteroids, prokinetics, Non-steroidal anti-inflammatory drugs (NSAIDs), strong anticholinergics, anticoagulant/anti-platelet aggregate therapy, anticoagulants, digoxin, theophylline, phenytoin. History of alcoholism or drug addiction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole 5 mg QD<br> | Drug: Ilaprazole<br>* Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.<br>|
| Experimental: Ilaprazole 20 mg QD<br> | Drug: Ilaprazole<br>* Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.<br>|
| Experimental: Ilaprazole 40 mg QD<br> | Drug: Ilaprazole<br>* Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.<br>|
| Active Comparator: Lansoprazole 30 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. |  | Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heartburn, erosive esophagitis, healing, population pharmacokinetics, Quality of Life (QoL)