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Completed

NCT Number: NCT05024721

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIP2101

Drug

Test drug

RLD2101

Drug

Reference drug

HPP2101

Drug

Placebo drug

HPP2102

Drug

Placebo drug

Primary outcomes

  1. Improvement rate of erosion

    Time frame: week 2

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

Secondary outcomes

  1. Cure rate of erosion

    Time frame: week 2

    percentage of subjects whose erosion is completely cured

  2. Cure rate of edema

    Time frame: week 2

    percentage of subjects whose edema is completely cured

  3. Improvement rate of erythema

    Time frame: week 2

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

  4. Improvement rate of hemorrage

    Time frame: week 2

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

  5. Improvement rate of GI symptoms

    Time frame: week 2

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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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