Back to resultsStudy to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Primary Purpose
Acute Gastritis, Chronic Gastritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP14012 X mg
DWP14012 X mg placebo
DWP14012 Y mg
DWP14012 Y mg placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastritis
Eligibility Criteria
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
Sites / Locations
- Hanyang University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
DWP14012 X mg QD
DWP14012 Y mg BID
placebo
Arm Description
Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo Evening: 1 tablet of DWP14012 Y mg placebo
Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg Evening: 1 tablet of DWP14012 Y mg
Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo Evening: 1 tablet of DWP14012 Y mg placebo
Outcomes
Primary Outcome Measures
Improvement rate of gastric mucosal erosion
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100
Secondary Outcome Measures
Cure rate of gastric mucosal erosion
Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100
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
Improvement rate of gastric mucosal erythema
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100
Improvement rate of gastric mucosal bleeding
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100
Improvement rate of subjective symptoms
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100
Full Information
NCT ID
NCT04341454
First Posted
April 9, 2020
Last Updated
December 20, 2021
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04341454
Brief Title
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Chronic Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
327 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWP14012 X mg QD
Arm Type
Experimental
Arm Description
Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
Evening: 1 tablet of DWP14012 Y mg placebo
Arm Title
DWP14012 Y mg BID
Arm Type
Experimental
Arm Description
Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
Evening: 1 tablet of DWP14012 Y mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
Evening: 1 tablet of DWP14012 Y mg placebo
Intervention Type
Drug
Intervention Name(s)
DWP14012 X mg
Intervention Description
DWP14012 X mg, tablet, orally, once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 X mg placebo
Intervention Description
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 Y mg
Intervention Description
DWP14012 Y mg, tablet, orally, twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DWP14012 Y mg placebo
Intervention Description
DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Improvement rate of gastric mucosal erosion
Description
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
Secondary Outcome Measure Information:
Title
Cure rate of gastric mucosal erosion
Description
Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
Title
Cure rate of gastric mucosal edema
Description
Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
Title
Improvement rate of gastric mucosal erythema
Description
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
Title
Improvement rate of gastric mucosal bleeding
Description
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
Title
Improvement rate of subjective symptoms
Description
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100
Time Frame
at 2 weeks after the IP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
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