Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: DWP14012 X mg placebo; Drug: DWP14012 Y mg; Drug: DWP14012 X mg; Drug: DWP14012 Y mg placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04341454

DW_DWP14012305

Details and patient eligibility

About

The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Full description

This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Enrollment: 327 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults between 19 and 75 years old based on the date of written agreement
• Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
• Those who had experienced one or more subjective symptoms of gastritis

Exclusion criteria

• Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
• Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 3 patient groups, including a placebo group

DWP14012 X mg QD

Experimental group

Description:

* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo

Treatment:

Drug: DWP14012 X mg

Drug: DWP14012 Y mg placebo

DWP14012 Y mg BID

Experimental group

Description:

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg * Evening: 1 tablet of DWP14012 Y mg

Treatment:

Drug: DWP14012 Y mg

Drug: DWP14012 X mg placebo

placebo

Placebo Comparator group

Description:

* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo

Treatment:

Drug: DWP14012 X mg placebo

Drug: DWP14012 Y mg placebo