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

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

A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 3

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

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 regurgitation 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 40mg
Orally, once daily
Drug: DWP14012 40mg
DWP14012 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
Other Names:
  • Nexium 40mg placebo
ACTIVE_COMPARATOR: Esomeprazole 40mg
Orally, once daily
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
Other Names:
  • Nexium 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Time Frame: at 8week
at 8week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Time Frame: at 4week
at 4week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Time Frame: at 4week and 8week
Mean change of the frequency or severity of main symptoms
at 4week and 8week
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Time Frame: at 4week and 8week
Mean change of the total score of GERD-HRQL
at 4week and 8week

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)

December 13, 2018

Primary Completion (ACTUAL)

August 7, 2019

Study Completion (ACTUAL)

August 7, 2019

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP14012301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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