Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healed Erosive Esophagitis
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagiti...
Eligibility Criteria
Inclusion
- Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
- Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
- 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
- Subjects who have Barrett's esophagus (\> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
- Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
- Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
- Subjects who have had a malignant tumor in the last 5 years
- 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)
- Subjects who cannot stop the existing erosive esophagitis treatment being taken
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT04341428
Start Date
July 2 2020
End Date
December 30 2021
Last Update
September 3 2020
Active Locations (1)
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1
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, South Korea, 07345