Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

Last updated: February 1, 2012
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Heartburn

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT00251693
T-EE04-084
U1111-1113-9373
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.)pylori.

  • Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2)receptor antagonists or sucralfate, drugs with significant anticholinergic effects,misoprostol or prokinetics

  • Use of antacids [except for study supplied Gelusil®]

  • Need for continuous anticoagulant therapy (blood thinners)

  • Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

  • History of dilatation of esophageal strictures, other than Schatzki's ring (a ring ofmucosal tissue near the lower esophageal sphincter)

  • Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretorycondition.

  • History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.

  • Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy

Study Design

Total Participants: 2038
Study Start date:
December 01, 2005
Estimated Completion Date:
January 31, 2007

Study Description

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

Connect with a study center

  • Box Hill,
    Australia

    Site Not Available

  • South Brisbane,
    Australia

    Site Not Available

  • Sofia,
    Bulgaria

    Site Not Available

  • Edmonton, Alberta
    Canada

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  • Winnipeg, Manitoba
    Canada

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  • St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Quebec City, Quebec
    Canada

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  • Regina, Saskatchewan
    Canada

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  • Saskatoon, Saskatchewan
    Canada

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  • Praha 6,
    Czech Republic

    Site Not Available

  • Dietzenback, HE
    Germany

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  • Hamburg, HH
    Germany

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  • Schweim, NW
    Germany

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  • Borna, SN
    Germany

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  • Gyula,
    Hungary

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  • Gujarat, Ahmedabad
    India

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  • Tamilnadu, Chennai
    India

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  • Rajasthan, Jaipur
    India

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  • Ludhiana, Punjab
    India

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  • Madurai, Tamina
    India

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  • Chennai,
    India

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  • Coimbatore,
    India

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  • Hyderabad,
    India

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  • New Delhi,
    India

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  • Vishakapatnam,
    India

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  • Riga,
    Latvia

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  • Kaunas,
    Lithuania

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  • Hamilton,
    New Zealand

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  • Lima,
    Peru

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  • Krakow,
    Poland

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  • Lubin,
    Poland

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  • Sopot,
    Poland

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  • Warzawa,
    Poland

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  • Bratislava,
    Slovakia

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  • Nitra,
    Slovakia

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  • Sucany,
    Slovakia

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  • Tmava,
    Slovakia

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  • Gauteng, Johannesburg
    South Africa

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  • Cape Town, WC
    South Africa

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  • Panorama, WC
    South Africa

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  • Pinelands, WC
    South Africa

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  • Plumstead, WC
    South Africa

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  • Somerset West, WC
    South Africa

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  • Pretoria,
    South Africa

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  • Alabaster, Alabama
    United States

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  • Birmingham, Alabama
    United States

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  • Huntsville, Alabama
    United States

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  • Phoenix, Arizona
    United States

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  • Scottsdale, Arizona
    United States

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  • Tucson, Arizona
    United States

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  • Anaheim, California
    United States

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  • Chula Vista, California
    United States

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  • Fullerton, 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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  • Long Beach, California
    United States

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  • Los Angeles, California
    United States

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  • Mission Hills, California
    United States

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  • Palm Springs, California
    United States

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  • Pasadena, California
    United States

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  • Redwood City, California
    United States

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  • San Diego, California
    United States

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  • San Luis Obispo, California
    United States

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  • Boulder, Colorado
    United States

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  • Colorado Springs, Colorado
    United States

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  • Lone Tree, Colorado
    United States

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  • Wheat Ridge, Colorado
    United States

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  • Waterbury, Connecticut
    United States

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  • Boynton Beach, Florida
    United States

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  • Jacksonsville, Florida
    United States

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  • Jupiter, Florida
    United States

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  • Kissimmee, Florida
    United States

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  • Lakeland, Florida
    United States

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  • New Port Richey, Florida
    United States

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  • Atlanta, Georgia
    United States

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  • Honolulu, Hawaii
    United States

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  • Arlington Heights, Illinois
    United States

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  • Chicago, Illinois
    United States

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  • Hines, Illinois
    United States

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  • Oak Park, Illinois
    United States

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  • Rockford, Illinois
    United States

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  • Clive, Iowa
    United States

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  • Dubuque, Iowa
    United States

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  • Newton, Kansas
    United States

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  • Shawnee Mission, Kansas
    United States

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  • Topeka, Kansas
    United States

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  • Metairie, Louisiana
    United States

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  • Shreveport, Louisiana
    United States

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  • Hollywood, Maryland
    United States

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  • Lutherville, Maryland
    United States

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  • Troy, Michigan
    United States

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  • Chaska, Minnesota
    United States

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  • Jackson, Mississippi
    United States

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  • Mexico, Missouri
    United States

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  • Saint Louis, Missouri
    United States

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  • Washington, Missouri
    United States

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  • Omaha, Nebraska
    United States

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  • Pahrump, Nevada
    United States

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  • Binghamton, New York
    United States

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  • Brooklyn, 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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  • Charlotte, North Carolina
    United States

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  • Elkin, North Carolina
    United States

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  • Greensboro, North Carolina
    United States

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  • Hickory, North Carolina
    United States

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  • Salisbury, North Carolina
    United States

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  • Statesville, North Carolina
    United States

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  • Winston-Salem, North Carolina
    United States

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  • Beachwood, Ohio
    United States

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  • Cincinnati, Ohio
    United States

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  • Mayfield Heights, Ohio
    United States

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  • Warren, Ohio
    United States

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  • Oklahoma City, Oklahoma
    United States

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  • Portland, Oregon
    United States

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  • Beaver Falls, Pennsylvania
    United States

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  • Duncansville, Pennsylvania
    United States

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  • Lansdale, Pennsylvania
    United States

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  • Bristol, Tennessee
    United States

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  • Chattanooga, Tennessee
    United States

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  • Hermitage, Tennessee
    United States

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  • Nashville, Tennessee
    United States

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  • Austin, Texas
    United States

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  • Beaumont, Texas
    United States

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  • Byran, Texas
    United States

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  • Corsicana, 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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  • San Antonio, Texas
    United States

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  • Bountiful, Utah
    United States

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  • Ogden, Utah
    United States

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  • Salt Lake City, Utah
    United States

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  • West Jordan, Utah
    United States

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  • Chesapeake, Virginia
    United States

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  • Danville, Virginia
    United States

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  • Spokane, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

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  • Monroe, Wisconsin
    United States

    Site Not Available

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