NCT05024721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

July 12, 2022

Conditions

Gastritis

Outcome Measures

Primary Outcomes (1)

  • Improvement rate of erosion

    percentage of subjects whose erosion score is improved by more than 50%

    week 2

Secondary Outcomes (5)

  • Cure rate of erosion

    week 2

  • Cure rate of edema

    week 2

  • Improvement rate of erythema

    week 2

  • Improvement rate of hemorrage

    week 2

  • Improvement rate of GI symptoms

    week 2

Study Arms (2)

HIP2101

EXPERIMENTAL

Taking HIP2101+HPP2102 once daily for 2 weeks.

Drug: HIP2101Drug: HPP2102

RLD2101

ACTIVE COMPARATOR

Taking RLD21012101+HPP2101 once daily for 2 weeks.

Drug: RLD2101Drug: HPP2101

Interventions

HIP2101DRUG

Test drug

HIP2101
RLD2101DRUG

Reference drug

RLD2101
HPP2101DRUG

Placebo drug

RLD2101
HPP2102DRUG

Placebo drug

HIP2101

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Lim H, Lee JY, Kwon YH, Moon HS, Park JK, Kim KB, Kim SW, Youn YH, Kim SG, Kim GH, Kim JW, Jang JY, Kwon KS, Kwon JG, Kim HS, Hong SJ, Lee KJ, Choi SC, Moon JS, Kim N, Park JJ, Lim Y, Hong SH, Jung HY. Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study. Gut Liver. 2025 Jul 15;19(4):519-527. doi: 10.5009/gnl240390. Epub 2025 Feb 14.

    PMID: 39949051DERIVED

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

August 9, 2021

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)