Clinical trial NCT01190657: Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastritis
Gastric Ulcer
Keywords: Teprenone
safety
efficacy
acute gastric lesion
chronic gastritis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 1184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a self-controlled, open, multiple-center clinical trial.


Eligibility criteria: Inclusion criteria

1. Age is over 18 years old , men or women
2. 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;
3. Signed the informed consent forms.

Exclusion criteria

1. Patients without inclusion criteria
2. Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
3. Patients with other digestive diseases.
4. Patients with operation on stomach and duodenum.
5. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
6. Patients with severity trauma, surgery, infection and shock.
7. Patients with any kind of tumor
8. Women either pregnant or breast feeding

Primary outcomes:
measure: Endoscopic results of ulcer lesion
timeFrame: 56 days
measure: Total effective rate
timeFrame: 56 days.
Secondary outcomes:
measure: Symptoms improved level
timeFrame: 56 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital of Beijing Military
city: Chongqing
country: China
facility: Chongqing First People's Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Hubei
country: China
facility: Wuhan Union Hospital
city: Hunan
country: China
facility: Changsha Central Hospital
city: Hunan
country: China
facility: Hunan Provincial People's Hospital
city: Jiangsu
country: China
facility: Nanjing First Hospital
city: Jiangsu
country: China
facility: Nanjing General Hospital of Nanjing Military Command
city: Jiangsu
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Jiangsu
country: China
facility: The Second Affiliated Hospital of Suzhou University
city: Jiangsu
country: China
facility: Wuxi #2 People's Hospital
city: Jilin
country: China
facility: Jilin University First Hospital
city: Liaoning
country: China
facility: Shengjing Hospital of China Medical University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Shanghai Renji Hospital
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanxi
country: China
facility: Shanxi Provincial People's Hospital
city: Shanxi
country: China
facility: The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
city: Sichuan
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
city: Sichuan
country: China
facility: The Affiliated Hospital of Luzhou Medical College
city: Sichuan
country: China
facility: Tongji Hospital
city: Zhejiang
country: China
facility: Hangzhou Red Cross Hospital
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang University
Study officials:
affiliation: Ruijin Hospital
name: Yaozong Yuan
role: PRINCIPAL_INVESTIGATOR
References: