Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Healed Erosive Esophagitis

Treatments: Drug: DWP14012 20 mg; Drug: Lansoprazole 15 mg Placebo; Drug: DWP14012 20 mg placebo; Drug: Lansoprazole 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04341428

DW_DWP14012303

Details and patient eligibility

About

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.

Enrollment: 406 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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406 participants in 2 patient groups

DWP14012 20mg

Experimental group

Description:

Orally, once daily

Treatment:

Drug: Lansoprazole 15 mg Placebo

Drug: DWP14012 20 mg

Lansoprazole 15mg

Active Comparator group

Description:

Orally, once daily

Treatment:

Drug: DWP14012 20 mg placebo

Drug: Lansoprazole 15 mg