Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
1 other identifier
interventional
1,184
1 country
26
Brief Summary
This is a self-controlled, open, multiple-center clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2010
Typical duration for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 1, 2013
March 1, 2013
2.8 years
August 26, 2010
March 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Endoscopic results of ulcer lesion
Heal rate = (healed cases + significant improved cases)/total cases administered Ă—100 %
56 days
Total effective rate
Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered Ă—100 %.
56 days.
Secondary Outcomes (1)
Symptoms improved level
56 days
Study Arms (2)
Selbex 50mg (14 days)
EXPERIMENTALSelbex 50mg (56 days)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age is over 18 years old , men or women
- Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
- Signed the informed consent forms.
You may not qualify if:
- Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
- Patients with other digestive diseases.
- Patients with operation on stomach and duodenum.
- Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
- Patients with severity trauma, surgery, infection and shock.
- Patients with any kind of tumor
- Women either pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (26)
Chinese People's Liberation Army General Hospital of Beijing Military
Beijing, China
Chongqing First People's Hospital
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Wuhan Union Hospital
Hubei, China
Changsha Central Hospital
Hunan, China
Hunan Provincial People's Hospital
Hunan, China
Nanjing First Hospital
Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Jiangsu, China
The Second Affiliated Hospital of Suzhou University
Jiangsu, China
Wuxi #2 People's Hospital
Jiangsu, China
Jilin University First Hospital
Jilin, China
Shengjing Hospital of China Medical University
Liaoning, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai First People's Hospital
Shanghai, China
Shanghai Renji Hospital
Shanghai, China
Shanghai Ruijin Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
Shanxi Provincial People's Hospital
Shanxi, China
The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
Shanxi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Sichuan, China
The Affiliated Hospital of Luzhou Medical College
Sichuan, China
Tongji Hospital
Sichuan, China
Hangzhou Red Cross Hospital
Zhejiang, China
The First Affiliated Hospital of Zhejiang University
Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaozong Yuan
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 27, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 1, 2013
Record last verified: 2013-03