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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01190657
Other study ID # P216
Secondary ID
Status Completed
Phase Phase 4
First received August 26, 2010
Last updated March 29, 2013
Start date May 2010
Est. completion date February 2013

Study information

Verified date March 2013
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority China: SFDA
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Selbex
50mg/day, 3 times/day, for 14 days
Selbex
50mg/day, 3 times/day, for 56 days

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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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