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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-04-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Erosive Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DWP14012 20mg

DWP14012 20mg, tablet, orally, once daily

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

tablet

DWP14012 placebo

Intervention Type DRUG

tablet

Esomeprazole placebo

Intervention Type DRUG

tablet

DWP14012 40mg

DWP14012 40mg, tablet, orally, once daily

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

tablet

DWP14012 placebo

Intervention Type DRUG

tablet

Esomeprazole placebo

Intervention Type DRUG

tablet

DWP14012 80mg

DWP14012 40mg\*2, tablet, orally, once daily

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

tablet

DWP14012 placebo

Intervention Type DRUG

tablet

Esomeprazole placebo

Intervention Type DRUG

tablet

Esomerpazole 40mg

Esomerpazole 40mg, tablet, orally, once daily

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

tablet

DWP14012 placebo

Intervention Type DRUG

tablet

Interventions

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DWP14012

tablet

Intervention Type DRUG

Esomeprazole

tablet

Intervention Type DRUG

DWP14012 placebo

tablet

Intervention Type DRUG

Esomeprazole placebo

tablet

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No