Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
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.
2 other identifiers
interventional
831
1 country
94
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
Shorter than P25 for phase_2
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 2, 2012
January 1, 2012
5 months
May 7, 2007
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
Week 4
Secondary Outcomes (1)
The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
Week 8
Study Arms (4)
Ilaprazole 5 mg QD
EXPERIMENTALIlaprazole 20 mg QD
EXPERIMENTALIlaprazole 40 mg QD
EXPERIMENTALLansoprazole 30 mg QD
ACTIVE COMPARATORInterventions
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (94)
Unknown Facility
Hueytown, Alabama, United States
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Huntsville, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Sherwood, Arkansas, United States
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Anaheim, California, United States
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Cypress, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Irvine, California, United States
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Lancaster, California, United States
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Mission Hills, California, United States
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Oakland, California, United States
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Orange, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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West Covina, California, United States
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Colorado Springs, Colorado, United States
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Longmont, Colorado, United States
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Pueblo, Colorado, United States
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Bristol, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Longwood, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Newnan, Georgia, United States
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Tucker, Georgia, United States
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Boise, Idaho, United States
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Moline, Illinois, United States
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Rockford, Illinois, United States
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Clive, Iowa, United States
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Davenport, Iowa, United States
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Dubuque, Iowa, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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Chevy Chase, Maryland, United States
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Prince Frederick, Maryland, United States
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Olive Branch, Mississippi, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Mexico, Missouri, United States
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Egg Harbor, New Jersey, United States
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Albuquerque, New Mexico, United States
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Binghamton, New York, United States
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Great Neck, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver Falls, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Goose Creek, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bryan, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Midvale, Utah, United States
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Ogden, Utah, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
May 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
February 2, 2012
Record last verified: 2012-01