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Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Primary Purpose

Esophagitis, Reflux, Esophagitis, Peptic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexlansoprazole MR
Dexlansoprazole MR
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis, Reflux focused on measuring Erosive Esophagitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dexlansoprazole MR 30 mg QD

Dexlansoprazole MR 60 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

First Posted
May 2, 2006
Last Updated
February 1, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00321737
Brief Title
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).
Detailed Description
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

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
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexlansoprazole MR 30 mg QD
Arm Type
Experimental
Arm Title
Dexlansoprazole MR 60 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 30 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 60 mg, 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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Chair
Facility Information:
City
Huntsville
State/Province
Alabama
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United States
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Tuscon
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Arizona
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Anaheim
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Azusa
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Carmichael
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Chula Vista
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Cypress
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Fresno
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Garden Grove
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Harrisburg
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Irvine
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Lancaster
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Mission Hills
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Oakland
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Orange
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Pasadena
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San Diego
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San Luis Obispo
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Boulder
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Colorado Springs
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Wheat Ridge
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Colorado
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Boynton Beach
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Jupiter
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Miami
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New Smyma Beach
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Ocala
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St. Petersburg
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Zephyrhills
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Atlanta
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Honolulu
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Boise
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Moline
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Oak Forrest
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Rockford
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Clive
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Lexington
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Baton Rouge
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Metairie
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Chevy Chase
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Hollywood
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Lutherville
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Prince Federick
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Chaska
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Jackson
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Egg Harbor Township
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Binghamton
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Rochester
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High Point
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Raleigh
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Bismark
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Dayton
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Mogadore
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Oklahoma City
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Medford
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Portland
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Duncansville
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Lansdale
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Anderson
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Mount Pleasant
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Bristol
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Chattanooga
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Germantown
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Jackson
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Kingsport
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Nashville
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Amarillo
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Fort Worth
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Houston
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San Antonio
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Ogden
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Utah
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Charlottesville
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Virginia
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Chesapeake
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Spokane
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Tacoma
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Milwaukee
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Monroe
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Kippa Ring
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Australia
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St. John's
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Newfoundland and Labrador
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Canada
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Newmarket
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Ontario
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Canada
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Richmond Hill
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Toronto
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Ontario
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Longueuil
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Quebec
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Regina
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Saskatchewan
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Canada
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Hradec Kralove
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Czech Republic
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Tallinn
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Estonia
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Riga
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Latvia
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Valmiera
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Latvia
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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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Lithuania
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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
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Sucany
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Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19210298
Citation
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.
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
PubMed Identifier
21129076
Citation
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.
Results Reference
result

Learn more about this trial

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

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