Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Acute Gastritis
Chronic Gastritis
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief 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
Detailed 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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT04341454
Start Date
June 2 2020
End Date
September 16 2021
Last Update
December 21 2021
Active Locations (1)
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1
Hanyang University Medical Center
Seoul, South Korea