Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis

February 1, 2012 updated by: Takeda

A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

Study Type

Interventional

Enrollment (Actual)

451

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

  • 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
      • 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
      • Jacksonville, 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 Jersey
      • New Brunswick, New Jersey, United States
    • New York
      • Bingampton, 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
      • 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
      • Bedford, Texas, United States
      • Bryan, 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:

  • Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

  • Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
  • Use of antacids (except for study supplied) throughout the study.
  • Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Need for continuous anticoagulant therapy.

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
Placebo Comparator: Placebo
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Experimental: Dexlansoprazole MR 60 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 90 mg QD
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Time Frame: 6 months
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
6 months
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
Time Frame: 6 months
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
Time Frame: 6 months
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.
6 months
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
Time Frame: 6 months
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked
6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
Time Frame: 6 months
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
Time Frame: 6 months
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
6 months

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

January 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 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-EE04-086
  • U1111-1114-1355 (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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