Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.
3 other identifiers
interventional
445
8 countries
98
Brief Summary
The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Shorter than P25 for phase_3
98 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
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedResults Posted
Study results publicly available
August 28, 2009
CompletedFebruary 3, 2012
February 1, 2012
1 year
May 2, 2006
February 20, 2009
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
6 months
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
6 months
Secondary Outcomes (4)
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
6 months
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
6 months
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 up to six months.
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Eligibility Criteria
You may qualify if:
- Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.
You may not qualify if:
- Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
- Use of antacids (except for study supplied) throughout the study.
- Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
- Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
- Need for continuous anticoagulant therapy.
- Evidence of uncontrolled systemic disease.
- Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
- Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (98)
Unknown Facility
Huntsville, Alabama, United States
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Tuscon, 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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Cypress, California, United States
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Fresno, California, United States
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Garden Grove, California, United States
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Harrisburg, 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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Pasadena, 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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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Wheat Ridge, Colorado, United States
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Boynton Beach, Florida, United States
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Jupiter, Florida, United States
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Miami, 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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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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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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Clive, Iowa, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, 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 Federick, Maryland, 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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Washington, Missouri, United States
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Egg Harbor, 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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Rochester, New York, United States
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Greensboro, 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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Bismarck, North Dakota, United States
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Dayton, Ohio, United States
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Mogadore, 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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Lansdale, Pennsylvania, 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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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, 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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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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Ogden, Utah, United States
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Charlottesville, Virginia, United States
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Chesapeake, Virginia, 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
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Kippa-Ring, Australia
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St. John's, Newfoundland and Labrador, Canada
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Newmarket, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Toronto, Ontario, Canada
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Longueuil, Quebec, Canada
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Regina, Saskatchewan, Canada
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Hradec Králové, Czechia
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Tallinn, Estonia
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Riga, Latvia
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Valmiera, Latvia
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Kaunas, Lithuania
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Panevezys, Lithuania
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Vilnius, Lithuania
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Bratislava, Slovakia
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Nitra, Slovakia
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Prešov, Slovakia
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Sučany, Slovakia
Related Publications (4)
Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.
PMID: 19210298RESULTPeura 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: 19735233RESULTWyrwich 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.
PMID: 20195905RESULTFriedlander 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: 21129076RESULT
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 and Development Center, Inc.
Study Officials
- STUDY CHAIR
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2006
First Posted
May 4, 2006
Study Start
May 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 3, 2012
Results First Posted
August 28, 2009
Record last verified: 2012-02