Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
NCT ID: NCT03736369
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2018-12-13
2019-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DWP14012 40mg
Orally, once daily
DWP14012 40mg
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg placebo
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg
Orally, once daily
DWP14012 40mg placebo
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Interventions
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DWP14012 40mg
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
DWP14012 40mg placebo
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg placebo
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days
Exclusion Criteria
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
20 Years
75 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Hanyang University Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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DW_DWP14012301
Identifier Type: -
Identifier Source: org_study_id
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