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

Phase 3

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: DWP14012 40mg; Drug: DWP14012 40mg placebo; Drug: Esomeprazole 40mg placebo; Drug: Esomeprazole 40mg

• Registration Number: NCT03736369
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2018-12-13
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 40mg	Esomeprazole 40mg placebo	Orally, once daily
Esomeprazole 40mg	Esomeprazole 40mg	Orally, once daily
DWP14012 40mg	DWP14012 40mg	Orally, once daily
Esomeprazole 40mg	DWP14012 40mg placebo	Orally, once daily

Primary Outcome Measures

Name	Time	Method
Cumulative healing rate of erosive esophagitis at 8week by endoscopy	at 8week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of