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

Primary Purpose

Acute Gastritis, Gastric Ulcer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Selbex
Selbex
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastritis focused on measuring Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese People's Liberation Army General Hospital of Beijing Military
  • Chongqing First People's Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • Wuhan Union Hospital
  • Changsha Central Hospital
  • Hunan Provincial People's Hospital
  • Nanjing First Hospital
  • Nanjing General Hospital of Nanjing Military Command
  • The Second Affiliated Hospital of Nanjing Medical University
  • The Second Affiliated Hospital of Suzhou University
  • Wuxi #2 People's Hospital
  • Jilin University First Hospital
  • Shengjing Hospital of China Medical University
  • Shanghai Changzheng Hospital
  • Shanghai First People's Hospital
  • Shanghai Renji Hospital
  • Shanghai Ruijin Hospital
  • Shanghai Sixth People's Hospital
  • Shanghai Tenth People's Hospital
  • Shanxi Provincial People's Hospital
  • The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
  • The Affiliated Hospital of Luzhou Medical College
  • Tongji Hospital
  • Hangzhou Red Cross Hospital
  • The First Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Selbex 50mg (14 days)

Selbex 50mg (56 days)

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic results of ulcer lesion
Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
Total effective rate
Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.

Secondary Outcome Measures

Symptoms improved level

Full Information

First Posted
August 26, 2010
Last Updated
March 29, 2013
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01190657
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Gastric Ulcer
Keywords
Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selbex 50mg (14 days)
Arm Type
Experimental
Arm Title
Selbex 50mg (56 days)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Selbex
Intervention Description
50mg/day, 3 times/day, for 14 days
Intervention Type
Drug
Intervention Name(s)
Selbex
Intervention Description
50mg/day, 3 times/day, for 56 days
Primary Outcome Measure Information:
Title
Endoscopic results of ulcer lesion
Description
Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
Time Frame
56 days
Title
Total effective rate
Description
Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.
Time Frame
56 days.
Secondary Outcome Measure Information:
Title
Symptoms improved level
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age is over 18 years old , men or women 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; Signed the informed consent forms. Exclusion criteria Patients without inclusion criteria Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease Patients with other digestive diseases. Patients with operation on stomach and duodenum. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids Patients with severity trauma, surgery, infection and shock. Patients with any kind of tumor Women either pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaozong Yuan
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese People's Liberation Army General Hospital of Beijing Military
City
Beijing
Country
China
Facility Name
Chongqing First People's Hospital
City
Chongqing
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Wuhan Union Hospital
City
Hubei
Country
China
Facility Name
Changsha Central Hospital
City
Hunan
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Hunan
Country
China
Facility Name
Nanjing First Hospital
City
Jiangsu
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Suzhou University
City
Jiangsu
Country
China
Facility Name
Wuxi #2 People's Hospital
City
Jiangsu
Country
China
Facility Name
Jilin University First Hospital
City
Jilin
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Liaoning
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Renji Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
City
Shanxi
Country
China
Facility Name
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
City
Sichuan
Country
China
Facility Name
The Affiliated Hospital of Luzhou Medical College
City
Sichuan
Country
China
Facility Name
Tongji Hospital
City
Sichuan
Country
China
Facility Name
Hangzhou Red Cross Hospital
City
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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