Gastric Ulcer
Conditions
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.
Interventions
DRUGHIP0612
Test drug
DRUGHPP2202
Placebo drug
DRUGRLD2204
Reference drug
DRUGHPP2201
Placebo drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing rate of gastric ulcer | week 8 | Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study |
Secondary
| Measure | Time frame |
|---|---|
| Healing rate of gastric ulcer | week 4 |
| Healing rate of gastric ulcer according to H.pylori infection status | week 4, 8 |
| Post-treatment resolution rate of GI symptoms | week 4, 8 |
Countries
South Korea
Outcome results
None listed