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

Erosive Gastroesophageal Reflux Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184324
• Other study ID #: DW_DWP14012002
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: June 2018
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Gastroesophageal Reflux Disease
• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

Drug:
• DWP14012
tablet
• Esomeprazole
tablet
• DWP14012 placebo
tablet
• Esomeprazole placebo
tablet

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Sungdong-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of subjects who were completely cured of mucosal defects by 8 weeks		8 weeks
Secondary	Ratio of subjects who were completely cured of mucosal defects by 4 weeks		4 weeks