Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

Phase 3

Completed

• Conditions: Gastritis
• Interventions: Drug: HIP2101; Drug: RLD2101; Drug: HPP2102; Drug: HPP2101

• Registration Number: NCT05024721
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-09
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIP2101	HIP2101	Taking HIP2101+HPP2102 once daily for 2 weeks.
HIP2101	HPP2102	Taking HIP2101+HPP2102 once daily for 2 weeks.
RLD2101	RLD2101	Taking RLD21012101+HPP2101 once daily for 2 weeks.
RLD2101	HPP2101	Taking RLD21012101+HPP2101 once daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Improvement rate of erosion	week 2	percentage of subjects whose erosion score is improved by more than 50%

Secondary Outcome Measures

Name	Time	Method
Cure rate of erosion	week 2	percentage of subjects whose erosion is completely cured
Cure rate of edema	week 2	percentage of subjects whose edema is completely cured
Improvement rate of erythema	week 2	percentage of subjects whose erythema score is improved by more than 50%
Improvement rate of hemorrage	week 2	percentage of subjects whose hemorrage score is improved by more than 50%
Improvement rate of GI symptoms	week 2	percentage of subjects whose GI symptoms score is improved by more than 50%

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of