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COMPLETEDPHASE3

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

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

NCT03736369•Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Hanyang University Medical Center

Seoul, South Korea

Key Dates

Start Date

December 13, 2018

Primary Completion Date

August 7, 2019

Completion Date

August 7, 2019

Last Updated

September 3, 2020

Enrollment

263

ACTUAL participants

Conditions

Erosive Esophagitis

Interventions

DWP14012 40mg

DRUG

DWP14012 40mg placebo

DRUG

Esomeprazole 40mg

DRUG

Esomeprazole 40mg placebo

DRUG

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

NCT05587309

Erosive Esophagitis

View study

COMPLETEDPHASE3

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

NCT01499368

Erosive Esophagitis

View study

COMPLETEDPHASE1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

Efficacy Study of Ilaprazole to Treat Erosive Esophgitis