Back to resultsEfficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Primary Purpose
Esophagitis, Reflux, Esophagitis, Peptic
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexlansoprazole MR
Dexlansoprazole MR
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Esophagitis, Reflux focused on measuring Erosive Esophagitis
Eligibility Criteria
Inclusion Criteria: Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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. 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. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study. Need for continuous anticoagulant therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
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.
Secondary Outcome Measures
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
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.
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
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
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
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.
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255164
Brief Title
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official Title
A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (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
The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
Detailed Description
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.
Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.
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
451 (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
Placebo
Arm Type
Placebo 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 for up to six months.
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 six months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Description
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Time Frame
6 months
Title
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
Description
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.
Time Frame
6 months
Title
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
Description
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
Time Frame
6 months
Title
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
Description
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.
Time Frame
6 months
Title
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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.
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.
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
Need for continuous anticoagulant therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
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Alabaster
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Danville
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Monroe
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12. IPD Sharing Statement
Citations:
PubMed Identifier
19681809
Citation
Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.
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
Learn more about this trial
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
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