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Trial record 1 of 19 for:    acute gastritis
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190657
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : April 1, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Acute Gastritis Gastric Ulcer Drug: Selbex Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1184 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Endoscopic results of ulcer lesion [ Time Frame: 56 days ]
    Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %

  2. Total effective rate [ Time Frame: 56 days. ]
    Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.


Secondary Outcome Measures :
  1. Symptoms improved level [ Time Frame: 56 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190657


Locations
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Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Principal Investigator: Yaozong Yuan Ruijin Hospital
More Information
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01190657    
Other Study ID Numbers: P216
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: March 2013
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Teprenone
safety
efficacy
acute gastric lesion
chronic gastritis
Additional relevant MeSH terms:
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Gastritis
Acute Disease
Stomach Ulcer
Ulcer
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Disease Attributes