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Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

NCT03736369 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2020-09-03

No results posted yet for this study

Summary

The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

DWP14012 40mg

DWP14012 40mg, tablet, orally, once daily for up to 8 weeks

DRUG

DWP14012 40mg placebo

DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

DRUG

Esomeprazole 40mg

Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks

DRUG

Esomeprazole 40mg placebo

Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2019-08-07
Completion
2019-08-07

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 NCT03736369 on ClinicalTrials.gov