Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
NCT ID: NCT04341428
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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UNKNOWN
PHASE3
406 participants
INTERVENTIONAL
2020-07-02
2021-12-30
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 20mg
Orally, once daily
DWP14012 20 mg
DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg Placebo
Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
Lansoprazole 15mg
Orally, once daily
DWP14012 20 mg placebo
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg
Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
Interventions
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DWP14012 20 mg
DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
DWP14012 20 mg placebo
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg
Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg Placebo
Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
Eligibility Criteria
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Inclusion Criteria
2. Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
3. Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis
Exclusion Criteria
2. Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
4. Subjects who have had a malignant tumor in the last 5 years
5. Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin \[100 mg/day\] which has been administered for prophylactic purpose before study entry is allowed)
6. Subjects who cannot stop the existing erosive esophagitis treatment being taken
19 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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The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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JINIL KIM, M.D., Ph.D.
Role: primary
Other Identifiers
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DW_DWP14012303
Identifier Type: -
Identifier Source: org_study_id
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