Gastric Ulcer Clinical Trial
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
Verified date | March 2013 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: SFDA |
Study type | Interventional |
This is a self-controlled, open, multiple-center clinical trial.
Status | Completed |
Enrollment | 1184 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | 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 |
Lead Sponsor | Collaborator |
---|---|
Eisai Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endoscopic results of ulcer lesion | Heal rate = (healed cases + significant improved cases)/total cases administered ×100 % | 56 days | No |
Primary | Total effective rate | Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %. | 56 days. | No |
Secondary | Symptoms improved level | 56 days | No |
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