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

Phase 3

• Conditions: Healed Erosive Esophagitis
• Interventions: Drug: DWP14012 20 mg; Drug: DWP14012 20 mg placebo; Drug: Lansoprazole 15 mg Placebo; Drug: Lansoprazole 15 mg

• Registration Number: NCT04341428
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Status Verified: 2020-07
• Study Start: 2020-07-02
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 406

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 20mg	Lansoprazole 15 mg Placebo	Orally, once daily
Lansoprazole 15mg	Lansoprazole 15 mg	Orally, once daily
DWP14012 20mg	DWP14012 20 mg	Orally, once daily
Lansoprazole 15mg	DWP14012 20 mg placebo	Orally, once daily

Primary Outcome Measures

Name	Time	Method
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24	at 24 week

Secondary Outcome Measures

Name	Time	Method
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12	at 12 week

Trial Locations

Locations (1)

The Catholic University of Korea, Yeouido ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of