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NCT03736369 Clinical Trial

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

Erosive Esophagitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03736369
Other study ID # DW_DWP14012301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 13, 2018
Est. completion date August 7, 2019

Study information
Verified date September 2020
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 263
Est. completion date August 7, 2019
Est. primary completion date August 7, 2019
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 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWP14012 40mg
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
• DWP14012 40mg placebo
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
• Esomeprazole 40mg
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
• Esomeprazole 40mg placebo
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

Locations
Country Name City State
Korea, Republic of Hanyang University Medical Center 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 Cumulative healing rate of erosive esophagitis at 8week by endoscopy at 8week
Secondary Cumulative healing rate of erosive esophagitis at 4week by endoscopy at 4week
Secondary Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) Mean change of the frequency or severity of main symptoms at 4week and 8week
Secondary Quality of Life assessment using GERD-HRQL(GERD-Health related quality life) Mean change of the total score of GERD-HRQL at 4week and 8week
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