Healed Erosive Esophagitis
Conditions
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 esophagitis confirmed on EGD after medication treatment.
Interventions
DRUGDWP14012 20 mg
DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
DRUGDWP14012 20 mg placebo
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed 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
1. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 | at 24 week |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12 | at 12 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| GERD-Health related quality life(HRQL) | at Weeks 4, 12, and 24 | Changes from baseline in the total score of GERD-HRQL at Weeks 4, 12, and 24(The total score could range from 0 to 50 and lower score was evaluated as higher quality of life) |
| Assessment on symptoms | Weeks 4, 12, and 24 | Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24 |
Countries
South Korea
Contacts
Primary ContactOh-Young Lee
Outcome results
None listed