Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
NCT ID: NCT00251693
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2038 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 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_CHAIR
Takeda
Locations
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Alabaster, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
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
Pasadena, California, United States
Redwood City, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Lone Tree, Colorado, United States
Wheat Ridge, Colorado, United States
Waterbury, Connecticut, United States
Boynton Beach, Florida, United States
Jacksonsville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Lakeland, Florida, United States
New Port Richey, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Hines, Illinois, United States
Oak Park, Illinois, United States
Rockford, Illinois, United States
Clive, Iowa, United States
Dubuque, Iowa, United States
Newton, Kansas, United States
Shawnee Mission, Kansas, United States
Topeka, Kansas, United States
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
Hollywood, Maryland, United States
Lutherville, Maryland, United States
Troy, Michigan, United States
Chaska, Minnesota, United States
Jackson, Mississippi, United States
Mexico, Missouri, United States
St Louis, Missouri, United States
Washington, Missouri, United States
Omaha, Nebraska, United States
Pahrump, Nevada, United States
Binghamton, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
Rochester, New York, United States
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
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Mayfield Heights, Ohio, United States
Warren, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Beaver Falls, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Hermitage, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Byran, 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
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Chesapeake, Virginia, United States
Danville, Virginia, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Box Hill, , Australia
South Brisbane, , Australia
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Québec, Quebec, Canada
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Prague, , Czechia
Hamburg, City state of Hamburg, Germany
Dietzenback, Hesse, Germany
Schweim, North Rhine-Westphalia, Germany
Borna, Saxony, Germany
Gyula, , Hungary
Gujarat, Ahmedabad, India
Tamilnadu, Chennai, India
Rajasthan, Jaipur, India
Ludhiana, Punjab, India
Madurai, Tamina, India
Chennai, , India
Coimbatore, , India
Hyderabad, , India
New Delhi, , India
Visakhapatnam, , India
Riga, , Latvia
Kaunas, , Lithuania
Hamilton, , New Zealand
Lima, , Peru
Krakow, , Poland
Lubin, , Poland
Sopot, , Poland
Warzawa, , Poland
Bratislava, , Slovakia
Nitra, , Slovakia
Sučany, , Slovakia
Tmava, , Slovakia
Gauteng, Johannesburg, South Africa
Cape Town, WC, South Africa
Panorama, WC, South Africa
Pinelands, WC, South Africa
Plumstead, WC, South Africa
Somerset West, WC, South Africa
Pretoria, , 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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U1111-1113-9373
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-EE04-084
Identifier Type: -
Identifier Source: org_study_id
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