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

Phase 4

Completed

• Conditions: Acute Gastritis; Gastric Ulcer
• Interventions: Drug: Selbex

• Registration Number: NCT01190657
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-29
• Last Update Posted: 2013-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selbex 50mg (14 days)	Selbex	-
Selbex 50mg (56 days)	Selbex	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptoms improved level	56 days

Trial Locations

Locations (26)

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

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