Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease

NCT03811080 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2019-06-25

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.

Conditions

  • Non-Erosive Gastroesophageal Reflux Disease

Interventions

DRUG

DWP14012 A mg

The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.

DRUG

DWP14012 B mg

The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.

DRUG

Placebo

The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 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
2019-02-07
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • South Korea

Study Locations

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Entities

Drugs

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 NCT03811080 on ClinicalTrials.gov