Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

September 1, 2020 updated by: Daewoong Pharmaceutical Co. LTD.

A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.

The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Sungdong-gu, Seoul, Korea, Republic of, 04763
        • Hanyang University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults between 20 and 75 years old based on the date of written agreement
  • Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
  • Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

  • Those who have undergone gastric acid suppression or gastric, esophageal surgery
  • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DWP14012 20mg
DWP14012 20mg, tablet, orally, once daily
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
EXPERIMENTAL: DWP14012 40mg
DWP14012 40mg, tablet, orally, once daily
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
EXPERIMENTAL: DWP14012 80mg
DWP14012 40mg*2, tablet, orally, once daily
Drug: DWP14012
tablet
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole placebo
tablet
ACTIVE_COMPARATOR: Esomerpazole 40mg
Esomerpazole 40mg, tablet, orally, once daily
Drug: DWP14012 placebo
tablet
Drug: Esomeprazole
tablet
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2017

Primary Completion (ACTUAL)

April 18, 2018

Study Completion (ACTUAL)

April 18, 2018

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (ACTUAL)

June 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP14012002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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