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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Erosive Gastroesophageal Reflux Disease

Treatments: Drug: DWP14012; Drug: Esomeprazole placebo; Drug: DWP14012 placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03184324

DW_DWP14012002

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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211 participants in 4 patient groups

DWP14012 20mg

Experimental group

Description:

DWP14012 20mg, tablet, orally, once daily

Treatment:

Drug: DWP14012

Drug: Esomeprazole placebo

Drug: DWP14012 placebo

DWP14012 40mg

Experimental group

Description:

DWP14012 40mg, tablet, orally, once daily

Treatment:

Drug: DWP14012

Drug: Esomeprazole placebo

Drug: DWP14012 placebo

DWP14012 80mg

Experimental group

Description:

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

Treatment:

Drug: DWP14012

Drug: Esomeprazole placebo

Drug: DWP14012 placebo

Esomerpazole 40mg

Active Comparator group

Description:

Esomerpazole 40mg, tablet, orally, once daily

Treatment:

Drug: Esomeprazole

Drug: DWP14012 placebo