Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
NCT ID: NCT00321984
Last Updated: 2011-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
947 participants
INTERVENTIONAL
2006-06-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Placebo
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
Interventions
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Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
* Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.
Exclusion Criteria
* Subjects with erosive esophagitis (EE) as shown by endoscopy.
* Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
* Subject has abnormal laboratory values.
* Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
* Subject known to have acquired immunodeficiency syndrome (AIDS).
* Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
* Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Use of antacids (except for study-supplied Gelusil® ).
* Use of drugs with significant anticholinergic effects.
* Subjects who cannot discontinue the use of misoprostol or prokinetics
* Need for continuous anticoagulant therapy.
* Females who are pregnant or lactating.
* History of gastrointestinal surgery except for simple oversew of ulcer.
* History of cancer within 3 years prior to screening.
* Subject has participated in a previous Dexlansoprazole study.
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Takeda Global Research & Development Center, Inc.
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Alabaster, Alabama, United States
Birmingham, Alabama, United States
Hueytown, Alabama, United States
Huntsville, Alabama, United States
Northport, Alabama, United States
Tallassee, Alabama, United States
Chandler, Arizona, United States
North Little Rock, Arizona, United States
Sun City, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Azusa, California, United States
Carmichael, California, United States
Chula Vista, California, United States
Clearwater, California, United States
Cypress, California, United States
Fountain Valley, California, United States
Fullerton, California, United States
Garden Grove, California, United States
Irvine, California, United States
Lancaster, California, United States
Mission Hills, California, United States
Oakland, California, United States
Orange, California, United States
Palm Springs, California, United States
Pasadena, California, United States
Redwood City, California, United States
San Diego, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Vista, California, United States
Westlake Village, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Littleton, Colorado, United States
Lone Tree, Colorado, United States
Wheat Ridge, Colorado, United States
Bristol, Connecticut, United States
Waterbury, Connecticut, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Holly Hill, Florida, United States
Jupitor, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
New Smyma Beach, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Conyers, Georgia, United States
Dunwoody, Georgia, United States
Stockbridge, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Moline, Illinois, United States
Oak Forrest, Illinois, United States
Rockford, Illinois, United States
Indianapolis, Indiana, United States
Clive, Iowa, United States
Dubuque, Iowa, United States
Overland, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Hollywood, Maryland, United States
Lutherville, Maryland, United States
Prince Frederick, Maryland, United States
Troy, Michigan, United States
Chaska, Minnesota, United States
Jackson, Mississippi, United States
Olive Branch, Mississippi, United States
Jefferson City, Missouri, United States
Mexico, Missouri, United States
Washington, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Egg Harbor Town, New Jersey, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Great Neck, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Harrisburg, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Statesville, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Franklin, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Mogadore, Ohio, United States
Sylvania, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Levittown, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Varnville, South Carolina, United States
Sioux Falls, South Dakota, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Bellaire, Texas, United States
Bryan, Texas, United States
Carollton, Texas, United States
Conroe, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
Midvale, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Norfold, Virginia, United States
Richmond, Virginia, United States
Lakewood, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Countries
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References
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Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.
Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.
Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.
Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. The effects of increasing body mass index on heartburn severity, frequency and response to treatment with dexlansoprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Apr;37(8):810-8. doi: 10.1111/apt.12270. Epub 2013 Mar 4.
Related Links
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For the Dexilant package insert refer to this link
Other Identifiers
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2006-000420-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1114-1935
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-GD05-137
Identifier Type: -
Identifier Source: org_study_id
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