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

NCT04341428 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

  • Healed Erosive Esophagitis

Interventions

DRUG

DWP14012 20 mg

DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks

DRUG

DWP14012 20 mg placebo

DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks

DRUG

Lansoprazole 15 mg

Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks

DRUG

Lansoprazole 15 mg Placebo

Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2021-08-30
Completion
2021-12-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341428 on ClinicalTrials.gov