Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
NCT ID: NCT00251745
Last Updated: 2011-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
908 participants
INTERVENTIONAL
2005-12-31
2006-05-31
Brief Summary
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Detailed Description
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Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (this posting, NCT00241745) and T-GD04-083 (NCT00251758), were combined and analyzed as a single larger study referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.
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 4 weeks.
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 90 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 60 mg, capsules, orally, once daily for 4 weeks.
Dexlansoprazole MR
Dexlansoprazole MR 90 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
* History of episodes of heartburn for 6 months or longer prior to screening.
* History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.
Exclusion Criteria
* Use of antacids (except for study supplied Gelusil®).
* Use of drugs with significant anticholinergic effects.
* Need for continuous anticoagulant (blood thinner) therapy.
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
* History of dilatation of esophageal strictures, other than a 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.
* Erosive Esophagitis seen on endoscopy during study screening.
* Co-existing diseases affecting the esophagus.
* Abnormal laboratory values that suggest significant clinical disease.
* Known acquired immunodeficiency syndrome (AIDS)
* Females pregnant or lactating.
* History of Alcohol abuse.
* History of Cancer within 3 years prior to screening.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
* 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
Huntsville, Alabama, 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
Redwood City, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
San Marino, 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
New Brunswick, New Jersey, 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
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
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
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
Countries
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References
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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.
Related Links
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For the Dexilant Package Insert refer to this link
Other Identifiers
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U1111-1114-0144
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-GD04-082
Identifier Type: -
Identifier Source: org_study_id
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