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Not Yet Recruiting NCT05656092

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

Conditions: Gastric Ulcer

Sex: All
Ages: 19 Years – 75 Years
Phase: PHASE3
Enrollment: 226
Sponsor: Hanmi Pharmaceutical Company Limited

Summary

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

Eligibility Criteria

Inclusion Criteria:19 years to 75 yearsDiagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopyPatients understood the consents and purpose of this trial and signed consent formExclusion Criteria:Patients who cannot perform endoscopyFinding 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 endoscopyHistory 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 strictureSevere hepatic diseaseSevere renal disease, CKDBleeding disorderHistory of malignancy or was treated for malignancy within 5 years before the start of the Visit 1Patients 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 agentPatients 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, aspirinRequirement of use of excluded medications during the studyHistory of allergic reaction to the medications used in this studyGlucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiencyUse of other investigational drugs within 30 days prior to the studyHistory of alcohol or drug abusePositive to pregnancy test, nursing mother, intention on pregnancyConsidered by investigator as not appropriate to participate in the clinical study with other reason

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05656092). StuddyBuddy aggregates publicly available trial information.