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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

831 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ilaprazole 5 mg QD

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.

Ilaprazole 20 mg QD

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.

Ilaprazole 40 mg QD

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.

Lansoprazole 30 mg QD

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

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.

Intervention Type DRUG

Ilaprazole

Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.

Intervention Type DRUG

Ilaprazole

Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.

Intervention Type DRUG

Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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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

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Countries

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United States

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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