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

NCT ID: NCT01190657

Last Updated: 2013-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Acute Gastritis Gastric Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Selbex 50mg (14 days)

Group Type EXPERIMENTAL

Selbex

Intervention Type DRUG

50mg/day, 3 times/day, for 14 days

Selbex 50mg (56 days)

Group Type EXPERIMENTAL

Selbex

Intervention Type DRUG

50mg/day, 3 times/day, for 56 days

Interventions

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Selbex

50mg/day, 3 times/day, for 14 days

Intervention Type DRUG

Selbex

50mg/day, 3 times/day, for 56 days

Intervention Type DRUG

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaozong Yuan

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Chinese People's Liberation Army General Hospital of Beijing Military

Beijing, , China

Site Status

Chongqing First People's Hospital

Chongqing, , China

Site Status

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Wuhan Union Hospital

Hubei, , China

Site Status

Changsha Central Hospital

Hunan, , China

Site Status

Hunan Provincial People's Hospital

Hunan, , China

Site Status

Nanjing First Hospital

Jiangsu, , China

Site Status

Nanjing General Hospital of Nanjing Military Command

Jiangsu, , China

Site Status

The Second Affiliated Hospital of Nanjing Medical University

Jiangsu, , China

Site Status

The Second Affiliated Hospital of Suzhou University

Jiangsu, , China

Site Status

Wuxi #2 People's Hospital

Jiangsu, , China

Site Status

Jilin University First Hospital

Jilin, , China

Site Status

Shengjing Hospital of China Medical University

Liaoning, , China

Site Status

Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Shanghai First People's Hospital

Shanghai, , China

Site Status

Shanghai Renji Hospital

Shanghai, , China

Site Status

Shanghai Ruijin Hospital

Shanghai, , China

Site Status

Shanghai Sixth People's Hospital

Shanghai, , China

Site Status

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status

Shanxi Provincial People's Hospital

Shanxi, , China

Site Status

The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University

Shanxi, , China

Site Status

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Sichuan, , China

Site Status

The Affiliated Hospital of Luzhou Medical College

Sichuan, , China

Site Status

Tongji Hospital

Sichuan, , China

Site Status

Hangzhou Red Cross Hospital

Zhejiang, , China

Site Status

The First Affiliated Hospital of Zhejiang University

Zhejiang, , China

Site Status

Countries

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China

Other Identifiers

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P216

Identifier Type: -

Identifier Source: org_study_id

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