A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients with Gastric Ulcer

Hanmi Pharmaceutical Company Limited1 site in 1 country199 target enrollmentMarch 6, 2023

ConditionsGastric Ulcer

InterventionsHIP0612 HPP2202 RLD2204 HPP2201

DrugsHIP0612 HPP2202 RLD2204 HPP2201

Overview

Phase: Phase 3
Intervention: HIP0612
Conditions: Gastric Ulcer
Sponsor: Hanmi Pharmaceutical Company Limited
Enrollment: 199
Locations: 1
Primary Endpoint: Healing rate of gastric ulcer
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 6, 2023

End Date

December 19, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanmi Pharmaceutical Company Limited

Responsible Party

Sponsor

Eligibility Criteria

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