Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
NCT ID: NCT00471094
Last Updated: 2012-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
831 participants
INTERVENTIONAL
2007-05-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ilaprazole 5 mg QD
Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Ilaprazole 20 mg QD
Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Ilaprazole 40 mg QD
Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Interventions
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Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Hueytown, Alabama, United States
Huntsville, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Sherwood, Arkansas, United States
Anaheim, California, United States
Cypress, California, United States
Encinitas, California, United States
Garden Grove, California, United States
Irvine, California, United States
Lancaster, California, United States
Mission Hills, California, United States
Oakland, California, United States
Orange, California, United States
Pasadena, California, United States
San Diego, California, United States
West Covina, California, United States
Colorado Springs, Colorado, United States
Longmont, Colorado, United States
Pueblo, Colorado, United States
Bristol, Connecticut, United States
Washington D.C., District of Columbia, United States
Longwood, Florida, United States
Miami, Florida, United States
New Smyrna Beach, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Conyers, Georgia, United States
Newnan, Georgia, United States
Tucker, Georgia, United States
Boise, Idaho, United States
Moline, Illinois, United States
Rockford, Illinois, United States
Clive, Iowa, United States
Davenport, Iowa, United States
Dubuque, 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
Kansas City, Missouri, United States
Mexico, Missouri, United States
Egg Harbor, New Jersey, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Great Neck, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Fayetteville, North Carolina, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Beaver Falls, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Lansdale, 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
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Bryan, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Midvale, Utah, United States
Ogden, Utah, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Countries
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Other Identifiers
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U1111-1127-6202
Identifier Type: REGISTRY
Identifier Source: secondary_id
Z-EE05-123
Identifier Type: -
Identifier Source: org_study_id
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