Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
2 other identifiers
interventional
908
1 country
95
Brief Summary
The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2005
Shorter than P25 for phase_3
95 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 8, 2005
CompletedFirst Posted
Study publicly available on registry
November 10, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedResults Posted
Study results publicly available
March 23, 2009
CompletedApril 28, 2011
April 1, 2011
5 months
November 8, 2005
February 26, 2009
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
4 weeks
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
4 weeks
Secondary Outcomes (2)
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
4 weeks
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
4 weeks
Study Arms (3)
Dexlansoprazole MR 60 mg QD
EXPERIMENTALDexlansoprazole MR 90 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Eligibility Criteria
You may qualify if:
- Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
- 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.
You may not qualify if:
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (95)
Unknown Facility
Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Chula Vista, 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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Palm Springs, 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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San Marino, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Lone Tree, Colorado, United States
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Wheat Ridge, Colorado, United States
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Waterbury, Connecticut, United States
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Boynton Beach, Florida, United States
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Jacksonsville, 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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New Port Richey, 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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Chicago, Illinois, United States
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Hines, Illinois, United States
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Oak Park, Illinois, United States
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Rockford, Illinois, United States
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Clive, Iowa, United States
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Dubuque, Iowa, 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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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Hollywood, Maryland, United States
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Lutherville, 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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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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Omaha, Nebraska, United States
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Pahrump, Nevada, United States
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New Brunswick, New Jersey, 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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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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Hickory, 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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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Mayfield Heights, Ohio, United States
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Warren, Ohio, United States
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Oklahoma City, Oklahoma, 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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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Hermitage, Tennessee, United States
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Nashville, Tennessee, 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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Corsicana, 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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San Antonio, 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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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
Unknown Facility
Monroe, Wisconsin, United States
Related Publications (1)
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.
PMID: 19735233RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP Clinical Sciences
- Organization
- Takeda Global Research & 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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 8, 2005
First Posted
November 10, 2005
Study Start
December 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
April 28, 2011
Results First Posted
March 23, 2009
Record last verified: 2011-04