Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis (NCT05024721) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
South Korea326 participantsStarted 2021-08-09
Plain-language summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion Criteria:
* 19≤ age ≤ 75
* Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
* Patients understood the consents and purpose of this trial and signed consent form
Exclusion Criteria:
* Patients who cannot perform endoscopy
* Active gastric or duodenal ulcer
* Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
* Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
* History of gastrointestinal surgery
* History of malignancy tumor, especially in the upper gastrointestinal tract
* Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
* Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
* Bleeding disorder
* Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
* Patients who have taken anticoagulants within a week before endoscopy
* Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
* History of allergic reaction to the medications used in this study
* Use of other investigational…