Chronic Erosive Gastritis Clinical Trial
Official title:
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
| Verified date | January 2014 |
| Source | Changhai Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
| Status | Completed |
| Enrollment | 156 |
| Est. completion date | June 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 ? 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Tongren Hospital | Beijing | Beijing |
| China | First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
| China | First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
| China | Changhai Hospital | Shanghai | Shanghai |
| China | Shanghai Xinhua Hospital | Shanghai | Shanghai |
| China | First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi |
| China | General Hospital of Tianjin Medical University | Tianjin | Tianjin |
| China | Zhongshan Hospital of Xiamen University | Xiamen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Changhai Hospital | Eisai China Inc. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group | 0,4 weeks | No | |
| Secondary | 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 | No | |
| Secondary | The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group | 4 weeks | No | |
| Secondary | 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 | No | |
| Secondary | The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group | 8 weeks | No |