Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
3 other identifiers
interventional
947
1 country
153
Brief Summary
The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive 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 Jun 2006
Shorter than P25 for phase_3
153 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
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedResults Posted
Study results publicly available
March 23, 2009
CompletedApril 28, 2011
April 1, 2011
6 months
May 2, 2006
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 30 mg QD
EXPERIMENTALDexlansoprazole MR 60 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
Eligibility Criteria
You may qualify if:
- Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
- Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
- Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.
You may not qualify if:
- Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
- Subjects with erosive esophagitis (EE) as shown by endoscopy.
- Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
- Subject has abnormal laboratory values.
- Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
- Subject known to have acquired immunodeficiency syndrome (AIDS).
- Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
- Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
- Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
- Use of antacids (except for study-supplied Gelusil® ).
- Use of drugs with significant anticholinergic effects.
- Subjects who cannot discontinue the use of misoprostol or prokinetics
- Need for continuous anticoagulant therapy.
- Females who are pregnant or lactating.
- History of gastrointestinal surgery except for simple oversew of ulcer.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (153)
Unknown Facility
Alabaster, 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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Northport, Alabama, United States
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Tallassee, Alabama, United States
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Chandler, Arizona, United States
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North Little Rock, Arizona, United States
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Sun City, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, 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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Clearwater, California, United States
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Cypress, California, United States
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Fountain Valley, 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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Mission Hills, 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 Francisco, California, United States
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San Luis Obispo, California, United States
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Vista, California, United States
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Westlake Village, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Littleton, 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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Bristol, Connecticut, United States
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Waterbury, Connecticut, United States
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Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Holly Hill, Florida, United States
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Jupitor, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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New Smyma 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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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Dunwoody, Georgia, United States
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Stockbridge, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Moline, Illinois, United States
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Oak Forrest, Illinois, United States
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Rockford, Illinois, United States
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Dubuque, Iowa, United States
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Overland, 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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Baltimore, Maryland, 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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Olive Branch, Mississippi, United States
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Jefferson City, Missouri, United States
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Mexico, Missouri, United States
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Washington, Missouri, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Egg Harbor Town, 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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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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Greensboro, North Carolina, United States
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Harrisburg, 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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Statesville, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Franklin, Ohio, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Mogadore, Ohio, United States
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Sylvania, 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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Duncansville, Pennsylvania, United States
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Harleysville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Varnville, 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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Bellaire, Texas, United States
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Bryan, Texas, United States
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Carollton, 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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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Midvale, 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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Charlottesville, Virginia, United States
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Chesapeake, Virginia, United States
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Norfold, Virginia, United States
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Richmond, Virginia, 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 (5)
Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1261-72. doi: 10.1111/j.1365-2036.2009.04013.x. Epub 2009 Apr 8.
PMID: 19392864RESULTPeura 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: 19735233RESULTFriedlander 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: 21129076RESULTPeura 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.
PMID: 24118079DERIVEDPeura 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.
PMID: 23451835DERIVED
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
May 2, 2006
First Posted
May 4, 2006
Study Start
June 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
April 28, 2011
Results First Posted
March 23, 2009
Record last verified: 2011-04