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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

August 26, 2010
March 29, 2013
May 2010
February 2013   (final data collection date for primary outcome measure)
  • 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 %.
  • Endoscopic results of ulcer lesion:Heal rate= (healed cases + significant improved cases)/total cases administered ×100 % [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Total effective rate= (healed cases + significant improved cases + effective cases)/total cases administered ×100 %. [ Time Frame: 56 days. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01190657 on ClinicalTrials.gov Archive Site
Symptoms improved level [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
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

This is a self-controlled, open, multiple-center clinical trial.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Gastritis
  • Gastric Ulcer
  • Drug: Selbex
    50mg/day, 3 times/day, for 14 days
  • Drug: Selbex
    50mg/day, 3 times/day, for 56 days
  • Experimental: Selbex 50mg (14 days)
    Intervention: Drug: Selbex
  • Experimental: Selbex 50mg (56 days)
    Intervention: Drug: Selbex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1184
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01190657
P216
No
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Principal Investigator: Yaozong Yuan Ruijin Hospital
Eisai Inc.
March 2013

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