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

Condition(s) targeted: Esophagitis

Intervention: Ilaprazole (Drug); Ilaprazole (Drug); Ilaprazole (Drug); Lansoprazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TAP Pharmaceutical Products Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.

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.

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.

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

Primary outcome: The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.

Secondary outcome: The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Huntsville, Alabama, United States

Hueytown, Alabama, United States

Tucson, Arizona, United States

Chandler, Arizona, United States

Tempe, Arizona, United States

Phoenix, Arizona, United States

Sherwood, Arkansas, United States

Anaheim, California, United States

Cypress, California, United States

San Diego, California, United States

Encinitas, California, United States

Orange, California, United States

Garden Grove, California, United States

Irvine, California, United States

Mission Hills, California, United States

Oakland, California, United States

Lancaster, California, United States

Pasadena, California, United States

West Covina, California, United States

Longmont, Colorado, United States

Colorado Springs, Colorado, United States

Pueblo, Colorado, United States

Bristol, Connecticut, United States

Washington, District of Columbia, United States

Zephyrhills, Florida, United States

Miami, Florida, United States

Longwood, Florida, United States

New Smyrna Beach, Florida, United States

Tampa, Florida, United States

Pembroke Pines, Florida, United States

Conyers, Georgia, United States

Newnan, Georgia, United States

Atlanta, Georgia, United States

Tucker, Georgia, United States

Boise, Idaho, United States

Moline, Illinois, United States

Rockford, Illinois, United States

Clive, Iowa, United States

Dubuque, Iowa, United States

Davenport, Iowa, United States

Wichita, Kansas, United States

Metairie, Louisiana, United States

Chevy Chase, Maryland, United States

Prince Frederick, Maryland, United States

Olive Branch, Mississippi, United States

Jefferson City, Missouri, United States

Mexico, Missouri, United States

Kansas City, Missouri, United States

Egg Harbor Township, New Jersey, United States

Albuquerque, New Mexico, United States

Rochester, New York, United States

Binghamton, New York, United States

Great Neck, New York, United States

Raleigh, North Carolina, United States

Greensboro, North Carolina, United States

Fayetteville, North Carolina, United States

Winston-Salem, North Carolina, United States

Chapel Hill, North Carolina, United States

Wilmington, North Carolina, United States

Dayton, Ohio, United States

Cincinnati, Ohio, United States

Norman, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Medford, Oregon, United States

Lansdale, Pennsylvania, United States

Harrisburg, Pennsylvania, United States

Beaver Falls, Pennsylvania, United States

Warwick, Rhode Island, United States

Anderson, South Carolina, United States

Charleston, South Carolina, United States

Goose Creek, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Sioux Falls, South Dakota, United States

Chattanooga, Tennessee, United States

Johnson City, Tennessee, United States

Nashville, Tennessee, United States

Bristol, Tennessee, United States

Bryan, Texas, United States

Houston, Texas, United States

Beaumont, Texas, United States

San Antonio, Texas, United States

Amarillo, Texas, United States

Fort Worth, Texas, United States

El Paso, Texas, United States

Austin, Texas, United States

Odessa, Texas, United States

Ogden, Utah, United States

Midvale, Utah, United States

Newport News, Virginia, United States

Norfolk, Virginia, United States

Spokane, Washington, United States

Monroe, Wisconsin, United States

Milwaukee, Wisconsin, United States

Starting date: May 2007
Ending date: October 2007
Last updated: June 13, 2008