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.”

This is a study to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg) compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Ilaprazole
  • 5 mg capsule orally once daily for 8 weeks
• Drug: Ilaprazole
  • 20 mg orally once daily for 8 weeks
• Drug: Ilaprazole
  • 40 mg orally once daily for 8 weeks
• Drug: Lansoprazole
  • 30 mg capsule orally once daily for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ilaprazole
• Experimental: 2
  • Ilaprazole
• Experimental: 3
  • Ilaprazole
• Active Comparator: 4
  • Lansoprazole

Primary Measures

• The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
  • Time Frame: Week 4
    Safety Issue?: No

Secondary Measures

• The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
  • Time Frame: Week 8
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471094

Study ID Number: Z-EE05-123

ClinicalTrials.gov Identifier: NCT00471094

Health Authority: United States: Food and Drug Administration