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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01190657
First received: August 26, 2010
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Gastritis
Gastric Ulcer
 Drug: Selbex
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Teprenone
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Endoscopic results of ulcer lesion [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %

  • Total effective rate [ Time Frame: 56 days. ] [ Designated as safety issue: No ]
    Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.


Secondary Outcome Measures:
  • Symptoms improved level [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 1184
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selbex 50mg (14 days) Drug: Selbex
50mg/day, 3 times/day, for 14 days
Experimental: Selbex 50mg (56 days) Drug: Selbex
50mg/day, 3 times/day, for 56 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190657

Locations
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
The Second Affiliated Hospital of Nanjing Medical University
Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Jiangsu, China
Nanjing First Hospital
Jiangsu, China
Wuxi #2 People's Hospital
Jiangsu, China
The Second Affiliated Hospital of Suzhou University
Jiangsu, China
Jilin University First Hospital
Jilin, China
Shengjing Hospital of China Medical University
Liaoning, China
Shanghai Sixth People's Hospital
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
Shanghai First People's Hospital
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai Renji Hospital
Shanghai, China
Shanghai Ruijin 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
The Affiliated Hospital of Luzhou Medical College
Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Sichuan, China
Tongji Hospital
Sichuan, China
Hangzhou Red Cross Hospital
Zhejiang, China
The First Affiliated Hospital of Zhejiang University
Zhejiang, China
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Principal Investigator: Yaozong Yuan Ruijin Hospital
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01190657     History of Changes
Other Study ID Numbers: P216
Study First Received: August 26, 2010
Last Updated: March 29, 2013
Health Authority: China: SFDA

Keywords provided by Eisai Inc.:
Teprenone
safety
efficacy
acute gastric lesion
chronic gastritis

Additional relevant MeSH terms:
Gastritis
Stomach Ulcer
Ulcer
Gastritis, Atrophic
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
 Peptic Ulcer
Pathologic Processes
Disease Attributes
Geranylgeranylacetone
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013