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

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

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

Study Overview

• Status: Completed
• Conditions: Gastritis
• Intervention / Treatment: Drug: HIP2101; Drug: HPP2102; Drug: RLD2101; Drug: HPP2101

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIP2101; Taking HIP2101+HPP2102 once daily for 2 weeks.	Drug: HIP2101; Test drug; Drug: HPP2102; Placebo drug
Active Comparator: RLD2101; Taking RLD21012101+HPP2101 once daily for 2 weeks.	Drug: RLD2101; Reference drug; Drug: HPP2101; Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of erosion	percentage of subjects whose erosion score is improved by more than 50%	week 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 7, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: HM-ESOL-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No