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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00251719
Registration number
NCT00251719
Ethics application status
Date submitted
8/11/2005
Date registered
10/11/2005
Date last updated
3/02/2012
Titles & IDs
Public title
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
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Scientific 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
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Secondary ID [1]
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U1111-1114-0058
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Secondary ID [2]
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T-EE04-085
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Esophagitis, Reflux
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Esophagitis, Peptic
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dexlansoprazole MR
Treatment: Drugs - Dexlansoprazole MR
Treatment: Drugs - Lansoprazole
Experimental: Dexlansoprazole MR 60 mg QD -
Experimental: Dexlansoprazole MR 90 mg QD -
Active comparator: Lansoprazole 30 mg QD -
Treatment: Drugs: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
Treatment: Drugs: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Treatment: Drugs: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
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Assessment method [1]
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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.
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Timepoint [1]
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8 Weeks
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Primary outcome [2]
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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
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Assessment method [2]
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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.
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Timepoint [2]
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8 Weeks
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Secondary outcome [1]
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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.
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Assessment method [1]
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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.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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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.
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Assessment method [2]
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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.
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Timepoint [2]
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8 Weeks
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Secondary outcome [3]
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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
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Assessment method [3]
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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.
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Timepoint [3]
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4 Weeks
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Secondary outcome [4]
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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
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Assessment method [4]
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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.
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Timepoint [4]
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4 Weeks
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Eligibility
Key inclusion criteria
* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2005
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2007
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Sample size
Target
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Accrual to date
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Final
2054
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Recruitment in Australia
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Recruitment hospital [1]
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- Adelaide
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- Bedford Park
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- Kippa Ring
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- Adelaide
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- Bedford Park
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- Kippa Ring
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Parktown, Gauteng
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00251719
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Trial related presentations / publications
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. 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. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Takeda
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, ...
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More Details
]
Journal
Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, A...
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Journal
Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Re...
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Journal
Friedlander EA, Pallentino J, Miller SK, VanBeuge ...
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Results are available at
https://clinicaltrials.gov/study/NCT00251719
Download to PDF