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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2022-03-07

Brief Summary

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

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Detailed Description

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Conditions

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Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HIP2101

Taking HIP2101+HPP2102 once daily for 2 weeks.

Group Type EXPERIMENTAL

HIP2101

Intervention Type DRUG

Test drug

HPP2102

Intervention Type DRUG

Placebo drug

RLD2101

Taking RLD21012101+HPP2101 once daily for 2 weeks.

Group Type ACTIVE_COMPARATOR

RLD2101

Intervention Type DRUG

Reference drug

HPP2101

Intervention Type DRUG

Placebo drug

Interventions

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HIP2101

Test drug

Intervention Type DRUG

RLD2101

Reference drug

Intervention Type DRUG

HPP2101

Placebo drug

Intervention Type DRUG

HPP2102

Placebo drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No