Back to resultsEfficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Primary Purpose
Esophagitis, Reflux, Esophagitis, Peptic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexlansoprazole MR
Dexlansoprazole MR
Lansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Esophagitis, Reflux focused on measuring Erosive Esophagitis
Eligibility Criteria
Inclusion Criteria: Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Lansoprazole 30 mg QD
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or 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.
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.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or 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.
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 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. If it doesn't meet the A criterion, it's counted as healed.
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00251719
Brief Title
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Reflux, Esophagitis, Peptic
Keywords
Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2054 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexlansoprazole MR 60 mg QD
Arm Type
Experimental
Arm Title
Dexlansoprazole MR 90 mg QD
Arm Type
Experimental
Arm Title
Lansoprazole 30 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Other Intervention Name(s)
TAK-390MR, Kapidex, Dexilant
Intervention Description
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Other Intervention Name(s)
TAK-390MR, Kapidex, Dexilant
Intervention Description
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid, AG-1749
Intervention Description
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
Description
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.
Time Frame
8 Weeks
Title
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
Description
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.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
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.
Description
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or 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.
Time Frame
Week 8
Title
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.
Description
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or 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.
Time Frame
8 Weeks
Title
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
Description
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.
Time Frame
4 Weeks
Title
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
Description
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.
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Anniston
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Alabama
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United States
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Hueytown
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Alabama
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United States
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Huntsville
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Alabama
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Tallassee
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Tuscaloosa
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Tucson
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Little Rock
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North Little Rock
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Azusa
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Carmichael
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Cypress
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Fresno
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Los Angeles
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Modesto
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Newport Beach
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Oakland
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Orange
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San Diego
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Santa Maria
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Littleton
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Colorado
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Longmont
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Wheat Ridge
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Colorado
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Bristol
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Connecticut
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Newark
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Delaware
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Fort Myers
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Miami
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Naples
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New Smyrna Beach
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Ocala
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Pembroke Pines
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Port Orange
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Saint Petersburg
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Sarasota
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Zephyrhills
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Atlanta
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Boise
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Moline
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North Chicago
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Oak Forest
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Evansville
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Indiana
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Indianapolis
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Newburgh
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Davenport
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Kansas City
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Wichita
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Lexington
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Louisville
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Baton Rouge
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Chevy Chase
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Prince Frederick
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Jackson
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Saint Louis
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Missoula
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Egg Harbor Township
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Albuquerque
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Chapel Hill
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Charlotte
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Greensboro
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Harrisburg
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High Point
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Raleigh
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Wilmington
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Winston-Salem
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Bismarck
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Akron
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Columbus
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Dayton
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Mogadore
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Oklahoma City
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Medford
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Portland
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Philadelphia
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Warwick
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Rhode Island
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Anderson
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Mt. Pleasant
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South Carolina
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United States
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Sioux Falls
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South Dakota
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Chattanooga
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Tennessee
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Germantown
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Tennessee
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United States
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Jackson
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Tennessee
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Johnson City
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Tennessee
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United States
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Kingsport
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Tennessee
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Amarillo
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Texas
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Conroe
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Dallas
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Fort Worth
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Houston
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Odessa
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Pharr
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Seguin
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Temple
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Texas
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Salt Lake City
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Utah
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Charlottesville
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Virginia
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Norfolk
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Virginia
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Richmond
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Virginia
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Bellevue
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Washington
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Lakewood
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Tacoma
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Washington
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Milwaukee
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Wisconsin
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Adelaide
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Australia
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Bedford Park
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Australia
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Kippa Ring
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Australia
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Sofia
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Bulgaria
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Hamilton
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Ontario
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Canada
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Newmarket
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Saskatoon
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Saskatchewan
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Canada
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Cundinamarca
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Bogota
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Colombia
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Barranquilla - Atlantico
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Colombia
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Hradec Kralove
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Czech Republic
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Ostrava - Hrabuvka
Country
Czech Republic
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Berlin
State/Province
BE
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Germany
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Stuttgart
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BW
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Germany
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Bochum
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NW
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Germany
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Bratislava
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Germany
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Hyderabad
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Andh Prad
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India
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Bangalore
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Kama
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India
City
Ludhiana
State/Province
Punjab
Country
India
City
Hyderabad
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India
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Pune
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India
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Hamburg
State/Province
HH
Country
Latvia
City
Balvi
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Latvia
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Riga
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Latvia
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Valmiera
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Latvia
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Panevezys
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Lithuania
City
Vinius
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Lithuania
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Auckland
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New Zealand
City
Lima
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Peru
City
Bialystok
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Poland
City
Bydgoszcz
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Poland
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Krakow
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Poland
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Mangalore
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Poland
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Warszawa
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Poland
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavi
Country
Russian Federation
City
Daugavpils
Country
Slovakia
City
Kosice
Country
Slovakia
City
Presov
Country
Slovakia
City
Bloemfontein
State/Province
Free State
Country
South Africa
City
Cape Town
State/Province
WC
Country
South Africa
City
Observatory, Cape Town
State/Province
WC
Country
South Africa
City
Parktown, Gauteng
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
19183157
Citation
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.
Results Reference
result
PubMed Identifier
19735233
Citation
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.
Results Reference
result
PubMed Identifier
20195905
Citation
Wyrwich 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.
Results Reference
result
PubMed Identifier
21129076
Citation
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.
Results Reference
result
PubMed Identifier
24118079
Citation
Peura 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.
Results Reference
derived
PubMed Identifier
23451835
Citation
Peura 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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
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