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

Completed · Phase 2

Conditions studied: Esophagitis

In brief

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.

Key facts

Study ID

NCT00471094

Run by

Takeda

People needed

831

Starts

2007-05-01

Expected to finish

2007-10-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

You may not qualify if…

• 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.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Sherwood, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Cypress, California, United States
• Study site — Encinitas, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Lancaster, California, United States
• Study site — Mission Hills, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — West Covina, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Longwood, Florida, United States
• Study site — Hueytown, Alabama, United States

Full record on ClinicalTrials.gov

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