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

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

Study Overview

• Status: Completed
• Conditions: Gastric Ulcer; Acute Gastritis
• Intervention / Treatment: Drug: Selbex; Drug: Selbex

• Study Type: Interventional
• Enrollment (Actual): 1184
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese People's Liberation Army General Hospital of Beijing Military
  • Chongqing, China
    • Chongqing First People's Hospital
  • Chongqing, China
    • The Second Affiliated Hospital of Chongqing Medical University
  • Hubei, China
    • Wuhan Union Hospital
  • Hunan, China
    • Changsha Central Hospital
  • Hunan, China
    • Hunan Provincial People's Hospital
  • Jiangsu, 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
  • Jilin, China
    • Jilin University First Hospital
  • Liaoning, China
    • Shengjing Hospital of China Medical University
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Shanghai First People's Hospital
  • Shanghai, China
    • Shanghai Tenth People's Hospital
  • Shanghai, China
    • Shanghai Renji Hospital
  • Shanghai, China
    • Shanghai Ruijin Hospital
  • Shanghai, China
    • Shanghai Sixth People's Hospital
  • Shanxi, China
    • Shanxi Provincial People's Hospital
  • Shanxi, China
    • The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
  • Sichuan, China
    • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
  • Sichuan, China
    • The Affiliated Hospital of Luzhou Medical College
  • Sichuan, China
    • Tongji Hospital
  • Zhejiang, China
    • Hangzhou Red Cross Hospital
  • Zhejiang, China
    • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selbex 50mg (14 days)	Drug: Selbex; 50mg/day, 3 times/day, for 14 days; Drug: Selbex; 50mg/day, 3 times/day, for 56 days
Experimental: Selbex 50mg (56 days)	Drug: Selbex; 50mg/day, 3 times/day, for 14 days; Drug: Selbex; 50mg/day, 3 times/day, for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic results of ulcer lesion	Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %	56 days
Total effective rate	Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.	56 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptoms improved level	56 days

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Principal Investigator: Yaozong Yuan, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 26, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Estimate): April 1, 2013
• Last Update Submitted That Met QC Criteria: March 29, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; Teprenone; acute gastric lesion; chronic gastritis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Gastritis; Acute Disease; Stomach Ulcer
• Other Study ID Numbers: P216