Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

This study is currently recruiting participants.

Verified May 2012 by Eisai Inc.

First Received on August 26, 2010. Last Updated on May 4, 2012 History of Changes

Sponsor:	Eisai Co., Ltd.
Information provided by (Responsible Party):	Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:	NCT01190657

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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Symptoms improved level [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Study Start Date:	May 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Selbex 50mg/day, 3 times/day, for 14 days
Experimental: 2	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

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.

Exclusion criteria

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 nonsteriodal 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

Contacts and Locations

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

Contacts

Contact: Yaozong Yuan

021-68825611

yuanyaozong@163.com

Locations

China, Shanghai
Shanghai Ruijin Hospital	Recruiting
Shanghai, Shanghai, China
Contact: Yaozong Yuan

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:	May 4, 2012
Health Authority:	China: SFDA

Keywords provided by Eisai Inc.:

Teprenone
safety
efficacy
acute gastric lesion of chronic gastritis with acute exacerbation or gastric ulcer

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 24, 2012