Back to resultsStudy to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Primary Purpose
Gastritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HIP2101
RLD2101
HPP2101
HPP2102
Sponsored by
About this trial
This is an interventional treatment trial for Gastritis
Eligibility Criteria
Inclusion Criteria:
- 19≤ age ≤ 75
- Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
- Patients understood the consents and purpose of this trial and signed consent form
Exclusion Criteria:
- Patients who cannot perform endoscopy
- Active gastric or duodenal ulcer
- Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
- Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
- History of gastrointestinal surgery
- History of malignancy tumor, especially in the upper gastrointestinal tract
- Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
- Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
- Bleeding disorder
- Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
- Patients who have taken anticoagulants within a week before endoscopy
- Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
- History of allergic reaction to the medications used in this study
- Use of other investigational drugs within 30 days prior to the study
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, intention on pregnancy
- Considered by investigator as not appropriate to participate in the clinical study with other reason
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIP2101
RLD2101
Arm Description
Taking HIP2101+HPP2102 once daily for 2 weeks.
Taking RLD21012101+HPP2101 once daily for 2 weeks.
Outcomes
Primary Outcome Measures
Improvement rate of erosion
percentage of subjects whose erosion score is improved by more than 50%
Secondary Outcome Measures
Cure rate of erosion
percentage of subjects whose erosion is completely cured
Cure rate of edema
percentage of subjects whose edema is completely cured
Improvement rate of erythema
percentage of subjects whose erythema score is improved by more than 50%
Improvement rate of hemorrage
percentage of subjects whose hemorrage score is improved by more than 50%
Improvement rate of GI symptoms
percentage of subjects whose GI symptoms score is improved by more than 50%
Full Information
NCT ID
NCT05024721
First Posted
August 23, 2021
Last Updated
July 12, 2022
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT05024721
Brief Title
Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
March 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
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 this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIP2101
Arm Type
Experimental
Arm Description
Taking HIP2101+HPP2102 once daily for 2 weeks.
Arm Title
RLD2101
Arm Type
Active Comparator
Arm Description
Taking RLD21012101+HPP2101 once daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
HIP2101
Intervention Description
Test drug
Intervention Type
Drug
Intervention Name(s)
RLD2101
Intervention Description
Reference drug
Intervention Type
Drug
Intervention Name(s)
HPP2101
Intervention Description
Placebo drug
Intervention Type
Drug
Intervention Name(s)
HPP2102
Intervention Description
Placebo drug
Primary Outcome Measure Information:
Title
Improvement rate of erosion
Description
percentage of subjects whose erosion score is improved by more than 50%
Time Frame
week 2
Secondary Outcome Measure Information:
Title
Cure rate of erosion
Description
percentage of subjects whose erosion is completely cured
Time Frame
week 2
Title
Cure rate of edema
Description
percentage of subjects whose edema is completely cured
Time Frame
week 2
Title
Improvement rate of erythema
Description
percentage of subjects whose erythema score is improved by more than 50%
Time Frame
week 2
Title
Improvement rate of hemorrage
Description
percentage of subjects whose hemorrage score is improved by more than 50%
Time Frame
week 2
Title
Improvement rate of GI symptoms
Description
percentage of subjects whose GI symptoms score is improved by more than 50%
Time Frame
week 2
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:
19≤ age ≤ 75
Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
Patients understood the consents and purpose of this trial and signed consent form
Exclusion Criteria:
Patients who cannot perform endoscopy
Active gastric or duodenal ulcer
Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
History of gastrointestinal surgery
History of malignancy tumor, especially in the upper gastrointestinal tract
Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
Bleeding disorder
Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
Patients who have taken anticoagulants within a week before endoscopy
Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
History of allergic reaction to the medications used in this study
Use of other investigational drugs within 30 days prior to the study
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason
Facility Information:
Facility Name
Asan 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 HIP2101 in Patients With Acute or Chronic Gastritis
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