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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/NCT00321737
Registration number
NCT00321737
Ethics application status
Date submitted
2/05/2006
Date registered
4/05/2006
Date last updated
3/02/2012
Titles & IDs
Public title
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
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Scientific title
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.
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Secondary ID [1]
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2006-000419-90
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Secondary ID [2]
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T-EE05-135
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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 - Placebo
Experimental: Dexlansoprazole MR 30 mg QD -
Experimental: Dexlansoprazole MR 60 mg QD -
Placebo Comparator: Placebo -
Treatment: Drugs: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Treatment: Drugs: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Treatment: Drugs: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
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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 Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
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Assessment method [1]
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Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
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Timepoint [1]
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6 months
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Primary outcome [2]
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Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
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Assessment method [2]
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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.
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Timepoint [2]
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6 months
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Secondary outcome [1]
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Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
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Assessment method [1]
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The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
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Assessment method [2]
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The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
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Assessment method [3]
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The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
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Assessment method [4]
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The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
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Timepoint [4]
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6 months
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Eligibility
Key inclusion criteria
- 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.
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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
- 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.
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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
1/05/2006
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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
1/05/2007
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Sample size
Target
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Accrual to date
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Final
445
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Kippa Ring
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Recruitment postcode(s) [1]
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- Kippa Ring
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Recruitment outside Australia
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United States of America
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Alabama
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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
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00321737
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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/NCT00321737
Download to PDF