Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
2 other identifiers
interventional
591
1 country
181
Brief Summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2006
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2005
CompletedFirst Posted
Study publicly available on registry
November 17, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 12, 2009
CompletedJuly 27, 2016
April 1, 2011
2.4 years
November 15, 2005
June 24, 2009
June 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
Mean Change From Baseline to Month 12 for Hemoglobin Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Hematocrit Values
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Baseline and Month 12
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Platelet Count Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Creatinine Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Calcium Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Total Bilirubin Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
Baseline and Month 12
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
Baseline and Month 12
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
Baseline and Month 12
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
Baseline and Month 12
Mean Change From Baseline to Month 12 for Pulse Rate
Baseline and Month 12
Changes From Baseline to Final Visit in Antrum Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Baseline and Final Visit (up to 12 months)
Changes From Baseline to Final Visit in Fundus Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Baseline and Final Visit (up to 12 months)
Secondary Outcomes (10)
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
Baseline and Month 1
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
Baseline and Month 3
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
Baseline and Month 6
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
Baseline and Month 9
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
Baseline and Month 12
- +5 more secondary outcomes
Study Arms (2)
Dexlansoprazole MR 60 mg QD
EXPERIMENTALDexlansoprazole MR 90 mg QD
EXPERIMENTALInterventions
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Eligibility Criteria
You may qualify if:
- Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.
You may not qualify if:
- Any condition that may require inpatient surgery during the course of the study.
- Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
- Use of antacids \[except for study supplied Gelusil®\].
- Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
- Evidence of uncontrolled systemic disease.
- Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
- Need to take blood thinners.
- Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
- Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
- Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
- Has had radiation or cryotherapy to the esophagus.
- Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
- Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
- History of alcohol abuse.
- Has acquired immunodeficiency syndrome.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (181)
Unknown Facility
Alabaster, Alabama, United States
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Hueytown, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Tallassee, Alabama, United States
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Tuscaloosa, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Anaheim, California, United States
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Azusa, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Cypress, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Garden Grove, California, United States
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Irvine, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Modesto, California, United States
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Newport Beach, California, United States
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Oakland, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Pasadena, California, United States
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Redwood City, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Santa Maria, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Lone Tree, Colorado, United States
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Longmont, Colorado, United States
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Wheat Ridge, Colorado, United States
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Bristol, Connecticut, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Boynton Beach, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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New Smyrna Beach, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Arlington Heights, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Hines, Illinois, United States
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Moline, Illinois, United States
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North Chicago, Illinois, United States
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Oak Forest, Illinois, United States
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Oak Park, Illinois, United States
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Rockford, Illinois, United States
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Springfield, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Newburgh, Indiana, United States
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Clive, Iowa, United States
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Davenport, Iowa, United States
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Dubuque, Iowa, United States
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Kansas City, Kansas, United States
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Newton, Kansas, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Chevy Chase, Maryland, United States
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Hollywood, Maryland, United States
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Lutherville, Maryland, United States
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Prince Frederick, Maryland, United States
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Troy, Michigan, United States
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Chaska, Minnesota, United States
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Jackson, Mississippi, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Mexico, Missouri, United States
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St Louis, Missouri, United States
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Washington, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Pahrump, Nevada, United States
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Egg Harbor, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Elkin, North Carolina, United States
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Greensboro, North Carolina, United States
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Harrisburg, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Mayfield Heights, Ohio, United States
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Mogadore, Ohio, United States
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Warren, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver Falls, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Hermitage, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bryan, Texas, United States
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Conroe, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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Pharr, Texas, United States
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San Antonio, Texas, United States
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Seguin, Texas, United States
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Tyler, Texas, United States
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Bountiful, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Charlottesville, Virginia, United States
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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Lakewood, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
Related Publications (3)
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.
PMID: 21129076RESULTDabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.
PMID: 21118280RESULTPeura 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.
PMID: 19735233RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The incidence of adverse events was considered one of the primary outcome measures of this study. These results are presented in the Adverse Events Section and are not reposted as a separate primary endpoint.
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2005
First Posted
November 17, 2005
Study Start
January 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 27, 2016
Results First Posted
August 12, 2009
Record last verified: 2011-04