A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients with Gastric Ulcer

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Gastric Ulcer

Treatments: Drug: HPP2201; Drug: RLD2204; Drug: HPP2202; Drug: HIP0612

Study type: Interventional

Funder types: Industry

Identifiers

NCT05656092

HM-AESOP-301

Details and patient eligibility

About

A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

Enrollment: 199 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 years to 75 years
• Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion criteria

• Patients who cannot perform endoscopy
• Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
• History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
• Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
• Severe hepatic disease
• Severe renal disease, CKD
• Bleeding disorder
• History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
• Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
• Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin
• Requirement of use of excluded medications during the study
• History of allergic reaction to the medications used in this study
• Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
• 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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199 participants in 2 patient groups

HIP0612

Experimental group

Description:

Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.

Treatment:

Drug: HIP0612

Drug: HPP2202

RLD2204

Active Comparator group

Description:

Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.

Treatment:

Drug: RLD2204

Drug: HPP2201