Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
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|ClinicalTrials.gov Identifier: NCT01190657|
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : April 1, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Acute Gastritis Gastric Ulcer||Drug: Selbex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Selbex 50mg (14 days)||
50mg/day, 3 times/day, for 14 days
|Experimental: Selbex 50mg (56 days)||
50mg/day, 3 times/day, for 56 days
- 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 %.
- Symptoms improved level [ Time Frame: 56 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age is over 18 years old , men or women
- 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;
- Signed the informed consent forms.
- Patients without inclusion criteria
- Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
- Patients with other digestive diseases.
- Patients with operation on stomach and duodenum.
- Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
- Patients with severity trauma, surgery, infection and shock.
- Patients with any kind of tumor
- Women either pregnant or breast feeding
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
|Principal Investigator:||Yaozong Yuan||Ruijin Hospital|
|Responsible Party:||Eisai Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||August 27, 2010 Key Record Dates|
|Last Update Posted:||April 1, 2013|
|Last Verified:||March 2013|
acute gastric lesion
Digestive System Diseases