Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis
2 other identifiers
interventional
2,054
16 countries
144
Brief Summary
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
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
144 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
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedResults Posted
Study results publicly available
March 23, 2009
CompletedFebruary 3, 2012
February 1, 2012
1.1 years
November 8, 2005
February 20, 2009
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
8 Weeks
Secondary Outcomes (4)
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Week 8
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
8 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
4 Weeks
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
4 Weeks
Study Arms (3)
Dexlansoprazole MR 60 mg QD
EXPERIMENTALDexlansoprazole MR 90 mg QD
EXPERIMENTALLansoprazole 30 mg QD
ACTIVE COMPARATORInterventions
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Eligibility Criteria
You may qualify if:
- Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).
You may not qualify if:
- Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
- Use of antacids \[except for study supplied Gelusil®\]
- Need for continuous anticoagulant therapy (Blood Thinners)
- Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
- History of dilatation of esophageal strictures, other than 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (144)
Unknown Facility
Anniston, Alabama, United States
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Hueytown, Alabama, United States
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Huntsville, Alabama, United States
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Tallassee, Alabama, United States
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Tuscaloosa, Alabama, 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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Azusa, California, United States
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Carmichael, California, United States
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Cypress, California, United States
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Fresno, California, United States
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Los Angeles, 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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San Diego, California, United States
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Santa Maria, California, United States
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Littleton, 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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Newark, Delaware, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Naples, 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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Boise, Idaho, 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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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Newburgh, Indiana, United States
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Davenport, Iowa, United States
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Kansas City, 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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Chevy Chase, Maryland, United States
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Prince Frederick, Maryland, 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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St Louis, Missouri, United States
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Missoula, Montana, 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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Chapel Hill, North Carolina, 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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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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Columbus, Ohio, 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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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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Chattanooga, Tennessee, United States
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Germantown, 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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Amarillo, Texas, United States
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Conroe, Texas, United States
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Dallas, 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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Seguin, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, 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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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Adelaide, Australia
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Bedford Park, Australia
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Kippa-Ring, Australia
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Sofia, Bulgaria
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Cundinamarca, Bogota D.C., Colombia
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Barranquilla - Atlantico, Colombia
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Hradec Králové, Czechia
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Ostrava - Hrabuvka, Czechia
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Stuttgart, Baden-Wurttemberg, Germany
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Bochum, North Rhine-Westphalia, Germany
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Berlin, State of Berlin, Germany
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Bratislava, Germany
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Hyderabad, Andh Prad, India
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Bangalore, Kama, India
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Ludhiana, Punjab, India
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Hyderabad, India
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Pune, India
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Hamburg, HH, Latvia
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Balvi, Latvia
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Riga, Latvia
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Valmiera, Latvia
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Panevezys, Lithuania
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Vinius, Lithuania
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Auckland, New Zealand
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Lima, Peru
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Bialystok, Poland
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Bydgoszcz, Poland
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Krakow, Poland
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Mangalore, Poland
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Warsaw, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Yaroslavi, Russia
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Daugavpils, Slovakia
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Košice, Slovakia
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Prešov, Slovakia
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Bloemfontein, Free State, South Africa
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Cape Town, WC, South Africa
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Observatory, Cape Town, WC, South Africa
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Parktown, Gauteng, South Africa
Related Publications (6)
Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x.
PMID: 19183157RESULTPeura 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: 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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2005
First Posted
November 10, 2005
Study Start
December 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
February 3, 2012
Results First Posted
March 23, 2009
Record last verified: 2012-02