Clinical trial NCT04341428: Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Official title: A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healed Erosive Esophagitis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 406
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24
timeFrame: at 24 week
Secondary outcomes:
measure: Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12
timeFrame: at 12 week
Other outcomes:
measure: GERD-Health related quality life(HRQL)
timeFrame: at Weeks 4, 12, and 24
measure: Assessment on symptoms
timeFrame: Weeks 4, 12, and 24
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital
Study officials:
References: