Overview

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

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Changhai Hospital
Collaborator:
Eisai China Inc.
Treatments:
Geranylgeranylacetone
Sucralfate
Criteria
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