Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
NCT ID: NCT00255151
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
451 participants
INTERVENTIONAL
2006-01-31
2006-11-30
Brief Summary
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Detailed Description
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Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Placebo
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Interventions
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Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_CHAIR
Takeda
Locations
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Anniston, Alabama, United States
Hueytown, Alabama, United States
Huntsville, Alabama, United States
Tallassee, Alabama, United States
Tuscaloosa, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Azusa, California, United States
Carmichael, California, United States
Cypress, California, United States
Fresno, California, United States
Los Angeles, California, United States
Modesto, California, United States
Newport Beach, California, United States
Oakland, California, United States
Orange, California, United States
San Diego, California, United States
Santa Maria, California, United States
Littleton, Colorado, United States
Longmont, Colorado, United States
Wheat Ridge, Colorado, United States
Bristol, Connecticut, United States
Newark, Delaware, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
New Smyrna Beach, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Champaign, Illinois, United States
Moline, Illinois, United States
North Chicago, Illinois, United States
Oak Forest, Illinois, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Davenport, Iowa, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Chevy Chase, Maryland, United States
Prince Frederick, Maryland, United States
Jackson, Mississippi, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Egg Harbor, New Jersey, United States
Albuquerque, New Mexico, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Akron, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Mogadore, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Sioux Falls, South Dakota, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
Amarillo, Texas, United States
Conroe, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Odessa, Texas, United States
Pharr, Texas, United States
Seguin, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Lakewood, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.
Related Links
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For the Dexilant package insert refer to this link
Other Identifiers
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U1111-1114-1767
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-EE04-087
Identifier Type: -
Identifier Source: org_study_id
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