A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism

Official Title
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A Prospective, Randomized, Double-blind, Double-dummy, Sucralfate Controlled, Multicenter Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

Conditions
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Chronic Erosive Gastritis

Intervention / Treatment
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* Drug: Teprenone capsule and placebo of sucralfate
* Drug: Sucralfate and placebo of teprenone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2 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: Suspected upper gastrointestinal malignancy by endoscopy Peptic ulcer and bleeding by endoscopy Severe cardiac, hepatic or renal insufficiency Severe neurological or psychological disease Pregnant or lactating women 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) History of allergic reaction to the medications used in this study Patients that investigators consider ineligible for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teprenone capsule<br> | Drug: Teprenone capsule and placebo of sucralfate<br>* Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.<br>|
| Active Comparator: sucralfate<br> | Drug: Sucralfate and placebo of teprenone<br>* Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group |  | 0,4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Erosive Gastritis, Teprenone, Sucralfate