Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
NCT ID: NCT00251719
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2054 participants
INTERVENTIONAL
2005-12-31
2007-01-31
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 60 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Interventions
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Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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 (UGI) hemorrhage within 4 weeks of the Screening endoscopy
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_DIRECTOR
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
Boise, Idaho, United States
Moline, Illinois, United States
North Chicago, Illinois, United States
Oak Forest, 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
Harrisburg, 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
Adelaide, , Australia
Bedford Park, , Australia
Kippa-Ring, , Australia
Sofia, , Bulgaria
Hamilton, Ontario, Canada
Newmarket, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Cundinamarca, Bogota D.C., Colombia
Barranquilla - Atlantico, , Colombia
Hradec Králové, , Czechia
Ostrava - Hrabuvka, , Czechia
Stuttgart, Baden-Wurttemberg, Germany
Bochum, North Rhine-Westphalia, Germany
Berlin, State of Berlin, Germany
Bratislava, , Germany
Hyderabad, Andh Prad, India
Bangalore, Kama, India
Ludhiana, Punjab, India
Hyderabad, , India
Pune, , India
Hamburg, HH, Latvia
Balvi, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Panevezys, , Lithuania
Vinius, , Lithuania
Auckland, , New Zealand
Lima, , Peru
Bialystok, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Mangalore, , Poland
Warsaw, , Poland
Moscow, , Russia
Saint Petersburg, , Russia
Yaroslavi, , Russia
Daugavpils, , Slovakia
Košice, , Slovakia
Prešov, , Slovakia
Bloemfontein, Free State, South Africa
Cape Town, WC, South Africa
Observatory, Cape Town, WC, South Africa
Parktown, Gauteng, , South Africa
Countries
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References
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Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.
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.
Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
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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U1111-1114-0058
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-EE04-085
Identifier Type: -
Identifier Source: org_study_id
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