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

February 1, 2012 updated by: Takeda

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2038

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia
      • South Brisbane, Australia
  • Bulgaria
      • Sofia, Bulgaria
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
    • Quebec
      • Quebec City, Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
      • Saskatoon, Saskatchewan, Canada
  • Czech Republic
      • Praha 6, Czech Republic
  • Germany
    • HE
      • Dietzenback, HE, Germany
    • HH
      • Hamburg, HH, Germany
    • NW
      • Schweim, NW, Germany
    • SN
      • Borna, SN, Germany
  • Hungary
      • Gyula, Hungary
  • India
      • Chennai, India
      • Coimbatore, India
      • Hyderabad, India
      • New Delhi, India
      • Vishakapatnam, India
    • Ahmedabad
      • Gujarat, Ahmedabad, India
    • Chennai
      • Tamilnadu, Chennai, India
    • Jaipur
      • Rajasthan, Jaipur, India
    • Punjab
      • Ludhiana, Punjab, India
    • Tamina
      • Madurai, Tamina, India
  • Latvia
      • Riga, Latvia
  • Lithuania
      • Kaunas, Lithuania
  • New Zealand
      • Hamilton, New Zealand
  • Peru
      • Lima, Peru
  • Poland
      • Krakow, Poland
      • Lubin, Poland
      • Sopot, Poland
      • Warzawa, Poland
  • Slovakia
      • Bratislava, Slovakia
      • Nitra, Slovakia
      • Sucany, Slovakia
      • Tmava, Slovakia
  • South Africa
      • Pretoria, South Africa
    • Johannesburg
      • Gauteng, Johannesburg, South Africa
    • WC
      • Cape Town, WC, South Africa
      • Panorama, WC, South Africa
      • Pinelands, WC, South Africa
      • Plumstead, WC, South Africa
      • Somerset West, WC, South Africa
  • United States
    • Alabama
      • Alabaster, Alabama, United States
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • Chula Vista, California, United States
      • Fullerton, California, United States
      • Garden Grove, California, United States
      • Irvine, California, United States
      • Lancaster, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Mission Hills, California, United States
      • Palm Springs, California, United States
      • Pasadena, California, United States
      • Redwood City, California, United States
      • San Diego, California, United States
      • San Luis Obispo, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Lone Tree, Colorado, United States
      • Wheat Ridge, Colorado, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Jacksonsville, Florida, United States
      • Jupiter, Florida, United States
      • Kissimmee, Florida, United States
      • Lakeland, Florida, United States
      • New Port Richey, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Chicago, Illinois, United States
      • Hines, Illinois, United States
      • Oak Park, Illinois, United States
      • Rockford, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
      • Dubuque, Iowa, United States
    • Kansas
      • Newton, Kansas, United States
      • Shawnee Mission, Kansas, United States
      • Topeka, Kansas, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Hollywood, Maryland, United States
      • Lutherville, Maryland, United States
    • Michigan
      • Troy, Michigan, United States
    • Minnesota
      • Chaska, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Mexico, Missouri, United States
      • Saint Louis, Missouri, United States
      • Washington, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Pahrump, Nevada, United States
    • New York
      • Binghamton, New York, United States
      • Brooklyn, New York, United States
      • Great Neck, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Elkin, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Hickory, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Beachwood, Ohio, United States
      • Cincinnati, Ohio, United States
      • Mayfield Heights, Ohio, United States
      • Warren, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Hermitage, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Byran, Texas, United States
      • Corsicana, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Danville, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Monroe, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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 of mucosal tissue near the lower esophageal sphincter)
  • Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexlansoprazole MR 60 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 90 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Active Comparator: Lansoprazole 30 mg QD
Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Other Names:
  • Prevacid
  • AG-1749

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Time Frame: 8 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
Time Frame: 8 weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Time Frame: 8 Weeks
Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
8 Weeks
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
Time Frame: 8 Weeks
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.
Time Frame: 4 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
4 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.
Time Frame: 4 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-EE04-084
  • U1111-1113-9373 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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