Status and phase
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About
The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
Enrollment
Sex
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Volunteers
Inclusion criteria
Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.*
* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
Outpatient (including inpatient for examination)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
305 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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