Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190657
• Other study ID #: P216
• 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

Related Conditions & MeSH terms

• Acute Disease
• Acute Gastritis
• Gastric Ulcer
• Gastritis
• Stomach Ulcer
• Ulcer

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