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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. )

Tracking Information
First Submitted Date  ICMJE August 26, 2010
First Posted Date  ICMJE August 27, 2010
Last Update Posted Date April 1, 2013
Study Start Date  ICMJE May 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
  • Endoscopic results of ulcer lesion [ Time Frame: 56 days ]
    Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
  • Total effective rate [ Time Frame: 56 days. ]
    Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Endoscopic results of ulcer lesion:Heal rate= (healed cases + significant improved cases)/total cases administered ×100 % [ Time Frame: 56 days ]
  • Total effective rate= (healed cases + significant improved cases + effective cases)/total cases administered ×100 %. [ Time Frame: 56 days. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)		 Symptoms improved level [ Time Frame: 56 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
Official Title  ICMJE 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
Brief Summary This is a self-controlled, open, multiple-center clinical trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Gastritis
  • Gastric Ulcer
Intervention  ICMJE
  • Drug: Selbex
    50mg/day, 3 times/day, for 14 days
  • Drug: Selbex
    50mg/day, 3 times/day, for 56 days
Study Arms  ICMJE
  • Experimental: Selbex 50mg (14 days)
    Intervention: Drug: Selbex
  • Experimental: Selbex 50mg (56 days)
    Intervention: Drug: Selbex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2013)		 1184
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2010)		 1200
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01190657
Other Study ID Numbers  ICMJE P216
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Original Responsible Party Yamada Koki, ECI
Current Study Sponsor  ICMJE Eisai Co., Ltd.
Original Study Sponsor  ICMJE Eisai Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yaozong Yuan Ruijin Hospital
PRS Account Eisai Inc.
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP