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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
2006-000419-90
Secondary ID [2] 0 0
T-EE05-135
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophagitis, Reflux 0 0
Esophagitis, Peptic 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
Timepoint [4] 0 0
6 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Kippa Ring
Recruitment postcode(s) [1] 0 0
- Kippa Ring
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maryland
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Canada
State/province [33] 0 0
Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Czech Republic
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Hradec Kralove
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Estonia
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Tallinn
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Latvia
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Riga
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Latvia
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Valmiera
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Lithuania
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Kaunas
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Presov
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Slovakia
State/province [47] 0 0
Sucany

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00321737
Trial related presentations / publications
Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00321737