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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Erosive Gastritis
• Intervention / Treatment: Drug: Teprenone capsule and placebo of sucralfate; Drug: Sucralfate and placebo of teprenone

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Tongren Hospital
  • Guangdong
    • Xiamen, Guangdong, China
      • Zhongshan Hospital of Xiamen University
  • Guangxi
    • Nanning, Guangxi, China
      • First Affiliated Hospital of Guangxi Medical University
  • Liaoning
    • Dalian, Liaoning, China
      • First Affiliated Hospital of Dalian Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital
    • Shanghai, Shanghai, China
      • Shanghai Xinhua hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • First Affiliated Hospital of Shanxi Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • General Hospital of Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Eisai China Inc.
• Investigators: Principal Investigator: Zhaoshen Li, Changhai Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Erosive Gastritis; Teprenone; Sucralfate
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Antineoplastic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Sucralfate; Geranylgeranylacetone
• Other Study ID Numbers: 2010-081