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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
The people assessing the outcomes
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
Anticipated
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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
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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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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Recruitment outside Australia
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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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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/ct2/show/NCT00251719
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Trial related presentations / publications
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00251719
Download to PDF