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

Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024721
• Other study ID #: HM-ESOL-301
• Status: Completed
• Phase: Phase 3
• Start date: August 9, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: July 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis

Intervention

Drug:
• HIP2101
Test drug
• RLD2101
Reference drug
• HPP2101
Placebo drug
• HPP2102
Placebo drug

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement rate of erosion	percentage of subjects whose erosion score is improved by more than 50%	week 2
Secondary	Cure rate of erosion	percentage of subjects whose erosion is completely cured	week 2
Secondary	Cure rate of edema	percentage of subjects whose edema is completely cured	week 2
Secondary	Improvement rate of erythema	percentage of subjects whose erythema score is improved by more than 50%	week 2
Secondary	Improvement rate of hemorrage	percentage of subjects whose hemorrage score is improved by more than 50%	week 2
Secondary	Improvement rate of GI symptoms	percentage of subjects whose GI symptoms score is improved by more than 50%	week 2