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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Gastritis

Treatments: Drug: HPP2102; Drug: RLD2101; Drug: HIP2101; Drug: HPP2101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05024721

HM-ESOL-301

Details and patient eligibility

About

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

Enrollment: 326 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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326 participants in 2 patient groups

HIP2101

Experimental group

Description:

Taking HIP2101+HPP2102 once daily for 2 weeks.

Treatment:

Drug: HIP2101

Drug: HPP2102

RLD2101

Active Comparator group

Description:

Taking RLD21012101+HPP2101 once daily for 2 weeks.

Treatment:

Drug: RLD2101

Drug: HPP2101