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

Chronic Gastritis Clinical Trial

Official title:

A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341454
• Other study ID #: DW_DWP14012305
• Status: Completed
• Phase: Phase 3
• Start date: June 2, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: December 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: September 16, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis
• Gastritis, Atrophic

Intervention

Drug:
• DWP14012 X mg
DWP14012 X mg, tablet, orally, once daily for 2 weeks
• DWP14012 X mg placebo
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks
• DWP14012 Y mg
DWP14012 Y mg, tablet, orally, twice daily for 2 weeks
• DWP14012 Y mg placebo
DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 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	Improvement rate of gastric mucosal erosion	Improvement rate (%) = (Number of effective cases(change of = 50% in erosion score) / Number of target cases) x 100	at 2 weeks after the IP administration
Secondary	Cure rate of gastric mucosal erosion	Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100	at 2 weeks after the IP administration
Secondary	Cure rate of gastric mucosal edema	Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100	at 2 weeks after the IP administration
Secondary	Improvement rate of gastric mucosal erythema	Improvement rate (%) = (Number of effective cases(change of = 50% in erythema score) / Number of target cases) x 100	at 2 weeks after the IP administration
Secondary	Improvement rate of gastric mucosal bleeding	Improvement rate (%) = (Number of effective cases(change of = 50% in bleeding score) / Number of target cases) x 100	at 2 weeks after the IP administration
Secondary	Improvement rate of subjective symptoms	Improvement rate (%) = (Number of effective cases(change of = 50% in subjective symptom score) / Number of target cases) x 100	at 2 weeks after the IP administration