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

This study has been completed.
Sponsor:
Collaborator:
Eisai China Inc.
Information provided by (Responsible Party):
Yinchun Zhang, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01284647
First received: January 26, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Chronic Erosive Gastritis
Drug: Teprenone capsule and placebo of sucralfate
Drug: Sucralfate and placebo of teprenone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group [ Time Frame: 0,4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284647

Locations
China, Beijing
Tongren Hospital
Beijing, Beijing, China
China, Guangdong
Zhongshan Hospital of Xiamen University
Xiamen, Guangdong, China
China, Guangxi
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
China, Liaoning
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
China, Shanghai
Changhai Hospital
Shanghai, Shanghai, China
Shanghai Xinhua Hospital
Shanghai, Shanghai, China
China, Shanxi
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
China, Tianjin
General Hospital of Tianjin Medical University
Tianjin, Tianjin, China
Sponsors and Collaborators
Changhai Hospital
Eisai China Inc.
Investigators
Principal Investigator: Zhaoshen Li Changhai Hospital
  More Information

No publications provided

Responsible Party: Yinchun Zhang, Dr., Changhai Hospital
ClinicalTrials.gov Identifier: NCT01284647     History of Changes
Other Study ID Numbers: 2010-081
Study First Received: January 26, 2011
Last Updated: January 13, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
Chronic Erosive Gastritis
Teprenone
Sucralfate

Additional relevant MeSH terms:
Gastritis
Gastrointestinal Hemorrhage
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Hemorrhage
Pathologic Processes
Disease Attributes
Sucralfate
Geranylgeranylacetone
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014