None listed
Conditions
Sponsors
Richwood Trading Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females aged 19 to 75 years, inclusive, at the time of the screening visit. 2) Subjects diagnosed with acute or chronic gastritis, presenting with at least one erosion confirmed by an upper gastrointestinal (GI) endoscopy performed within 7 days prior to the randomization visit (Visit 2) (excluding erosions in the esophagus and duodenum). 3) Women of childbearing potential (WOCBP)* or men who agree to practice complete abstinence or maintain contraception using the following methods during the study period and for 2 weeks after the last dose of the investigational product. Note: Periodic abstinence (e.g., calendar, symptothermal, or post-ovulation methods), withdrawal (coitus interruptus), use of spermicide alone, lactational amenorrhea method (LAM), and the concurrent use of female and male condoms are not considered acceptable contraceptive methods. ? Female subjects or female partners of male subjects: Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), Intrauterine Device (IUD), Intrauterine System (IUS), bilateral tubal occlusion, or sexual abstinence. ? Male subjects: Surgical sterilization (vasectomy) or sexual abstinence. Footnotes for Criterion 3: * WOCBP (Women of Childbearing Potential): All women with the potential to become pregnant, from menarche until menopause‡, unless permanently sterile†. † Permanent sterilization methods: Hysterectomy, bilateral salpingectomy, etc. ‡ Menopause: Amenorrhea for 12 months without an alternative medical cause. 4) Subjects who have provided voluntary written informed consent to participate in the study after receiving a sufficient explanation and fully understanding the objective and procedures of the clinical trial, the characteristics of the investigational product, and the anticipated adverse events.
Exclusion criteria
Exclusion criteria: [Disease and Medical History] 1) Subjects with the following lesions confirmed or concurrently present on upper gastrointestinal (GI) endoscopy at Screening (Visit 1): active or healing peptic or iatrogenic ulcers (however, subjects with scars are eligible for enrollment), reflux esophagitis, Barrett's esophagus (> 3 cm), gastroesophageal varices, esophageal stricture, etc. 2) Subjects with a history of gastric acid-suppressing surgery, or gastric or esophageal surgery prior to Screening (Visit 1). 3) Subjects diagnosed with, or with a history of, Zollinger-Ellison syndrome at Screening (Visit 1). 4) Subjects with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, Behçet's disease), primary esophageal motility disorders, or pancreatitis at Screening (Visit 1). 5) Subjects with a history of malignancy within 5 years prior to Screening (Visit 1). (However, subjects who were completely cured after treatment and have had no recurrence for = 5 years may be enrolled at the investigator's discretion. Subjects with a history of upper GI malignancy are excluded regardless of the time since cure.) Exception: For basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, and carcinoma in situ of other sites, subjects with a history within 5 years who were completely cured and have had no recurrence for = 3 years may be enrolled at the investigator's discretion. 6) Subjects with a current diagnosis or history of thrombosis-related diseases (e.g., cerebral thrombosis, myocardial infarction, thrombophlebitis, venous thrombosis, etc.) at Screening (Visit 1). 7) Subjects diagnosed with disseminated intravascular coagulation (DIC) at Screening (Visit 1). 8) Subjects with concurrent hepatic, renal, cardiac, pulmonary, or hematologic diseases that, in the opinion of the investigator, may affect the efficacy and safety assessments. 9) Subjects with rare hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 10) Subjects with a history of hypersensitivity to any component of the investigational product (e.g., Tartrazine [Yellow No. 4], etc.). 11) Subjects with clinically significant psychiatric disorders at Screening (Visit 1). [Prior and Concomitant Medications] 12) Subjects who received the following medications within 2 weeks prior to Screening (Visit 1) or require their continuous use during the study period: ? Gastric mucosal protectants other than the investigational product (e.g., Sucralfate, Rebamipide, Sulglycotide, Artemisia herb extract, etc.) ? Gastric acid suppressants (e.g., Proton Pump Inhibitors [PPIs], H2 receptor antagonists, anti-gastrin agents, Potassium-Competitive Acid Blockers [P-CABs]) ? Antacids (e.g., Aluminium Hydroxide, Magnesium Hydroxide, Calcium Carbonate, Sodium Bicarbonate, etc.) ? Prostaglandin preparations ? Anticholinergics ? Gastrointestinal antispasmodics ? Gastrointestinal prokinetics (e.g., Mosapride, Metoclopramide, etc.) ? Other drugs for the treatment of gastritis * Medications used as premedication for upper GI and colon endoscopies (e.g., Midazolam, Propofol, Simethicone, Hyoscine Butylbromide, Cimetropium Bromide, Coolprep, Magmil, Pethidine, Gasocol, Polyethylene Glycol, Urea, etc.) are permitted. ** For Bismuth preparations, a 4-week washout period is required. 13) Subjects who received the following medications within 2 weeks prior to Randomization (Visit 2) or require their continuous use during the study period: ?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erosion improvement rate on upper gastrointestinal endoscopy assessed by independent investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Erosion improvement rate on upper gastrointestinal endoscopy assessed by investigator;Erosion cure rate on upper gastrointestinal endoscopy;Edema cure rate on upper gastrointestinal endoscopy;Improvement rates of redness on upper gastrointestinal endoscopy;Improvement rates of hemorrhage on upper gastrointestinal endoscopy;Improvement rate of subjective symptoms;Safety assessment (adverse events, clinical laboratory tests, vital signs, physical examination, electrocardiogram) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunmi Lee
Seoul National University Hospital
Outcome results
None listed