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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255164
First Posted: November 17, 2005
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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).

Condition Intervention Phase
Esophagitis, Reflux Esophagitis, Peptic Drug: Dexlansoprazole MR Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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

  • 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.

  • 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.


Enrollment: 451
Study Start Date: January 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Dexlansoprazole MR 90 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Placebo Comparator: Placebo Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255164


  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
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
United States, Colorado
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Lone Tree, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Waterbury, Connecticut, United States
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
United States, Georgia
Atlanta, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
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
United States, Iowa
Clive, Iowa, United States
Dubuque, Iowa, United States
United States, Kansas
Newton, Kansas, United States
Shawnee Mission, Kansas, United States
Topeka, Kansas, United States
United States, Louisiana
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Hollywood, Maryland, United States
Lutherville, Maryland, United States
United States, Michigan
Troy, Michigan, United States
United States, Minnesota
Chaska, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Mexico, Missouri, United States
Saint Louis, Missouri, United States
Washington, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Pahrump, Nevada, United States
United States, New Jersey
New Brunswick, New Jersey, United States
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
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
United States, Ohio
Cincinnati, Ohio, United States
Mayfield Heights, Ohio, United States
Warren, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Beaver Falls, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
United States, Tennessee
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Hermitage, Tennessee, United States
Nashville, Tennessee, United States
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
United States, Utah
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Chesapeake, Virginia, United States
Danville, Virginia, United States
United States, Washington
Spokane, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Publications:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00255164     History of Changes
Other Study ID Numbers: T-EE04-086
U1111-1114-1355 ( Registry Identifier: WHO )
First Submitted: November 15, 2005
First Posted: November 17, 2005
Results First Submitted: February 20, 2009
Results First Posted: August 28, 2009
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Takeda:
Erosive Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action