A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
Phase 4
Completed
- Conditions
- Chronic Erosive Gastritis
- Interventions
- Registration Number
- NCT01284647
- Lead Sponsor
- Changhai Hospital
- Brief Summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
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 β₯ 2
- Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score β₯ 4 (Rome β ’ 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teprenone capsule Teprenone capsule and placebo of sucralfate - sucralfate Sucralfate and placebo of teprenone -
- Primary Outcome Measures
Name Time Method The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group 0,4 weeks
- Secondary Outcome Measures
Name Time Method 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 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 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 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group 8 weeks
Trial Locations
- Locations (8)
Shanghai Xinhua Hospital
π¨π³Shanghai, Shanghai, China
Tongren Hospital
π¨π³Beijing, Beijing, China
First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
Zhongshan Hospital of Xiamen University
π¨π³Xiamen, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Changhai Hospital
π¨π³Shanghai, Shanghai, China
First Affiliated Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
General Hospital of Tianjin Medical University
π¨π³Tianjin, Tianjin, China