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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Erosive Esophagitis

Treatments: Drug: Esomeprazole 40mg placebo; Drug: DWP14012 40mg; Drug: DWP14012 40mg placebo; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03736369

DW_DWP14012301

Details and patient eligibility

About

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.

Enrollment: 263 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 2 patient groups

DWP14012 40mg

Experimental group

Description:

Orally, once daily

Treatment:

Drug: DWP14012 40mg

Drug: Esomeprazole 40mg placebo

Esomeprazole 40mg

Active Comparator group

Description:

Orally, once daily

Treatment:

Drug: Esomeprazole 40mg

Drug: DWP14012 40mg placebo