Chronic Erosive Gastritis
Conditions
Keywords
Chronic Erosive Gastritis, Teprenone, Sucralfate
Brief summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
Interventions
DRUGTeprenone capsule and placebo of sucralfate
Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.
DRUGSucralfate and placebo of teprenone
Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks
Sponsors
Eisai China Inc.
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years old 2. Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2 3. Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)
Exclusion criteria
1. Suspected upper gastrointestinal malignancy by endoscopy 2. Peptic ulcer and bleeding by endoscopy 3. Severe cardiac, hepatic or renal insufficiency 4. Severe neurological or psychological disease 5. Pregnant or lactating women 6. Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen) 7. History of allergic reaction to the medications used in this study 8. Patients that investigators consider ineligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group | 0,4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group | 4 weeks |
| The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group | 4 weeks |
| The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group | 4 and 8 weeks |
| The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group | 8 weeks |
Countries
China
Outcome results
None listed