A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
Information source: Changhai Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Erosive Gastritis
Intervention: Teprenone capsule and placebo of sucralfate (Drug); Sucralfate and placebo of teprenone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Changhai Hospital Official(s) and/or principal investigator(s): Zhaoshen Li, Principal Investigator, Affiliation: Changhai Hospital
Summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic
erosive gastritis and its therapeutic mechanism
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
Secondary outcome: The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate groupThe difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Tongren Hospital, Beijing, Beijing, China
Zhongshan Hospital of Xiamen University, Xiamen, Guangdong, China
First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 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
Additional Information
Starting date: February 2011
Last updated: January 13, 2014
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