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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Dec 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HIP0612 for patients with gastric ulcers, which are sore spots in the stomach lining that can cause pain and discomfort. The trial is in Phase 3, meaning it is testing the treatment's effectiveness and safety in a larger group of people. It is currently recruiting participants aged between 19 and 75 years who have been diagnosed with active gastric ulcers. To join the study, patients must understand the purpose of the trial and agree to participate by signing a consent form.

If you or someone you know is considering participating, it’s important to know that certain health conditions may exclude you from the study. For example, individuals with a history of severe liver or kidney disease, specific types of ulcers, or certain surgeries may not be eligible. Participants will undergo regular check-ups and will be closely monitored throughout the trial to ensure their safety. This study aims to provide valuable information about HIP0612 and help improve treatment options for gastric ulcers in the future.

Gender

ALL

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
• • 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