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History of Changes for Study: NCT01190657
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
Latest version (submitted March 29, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 26, 2010 None (earliest Version on record)
2 March 9, 2011 Study Status and Sponsor/Collaborators
3 September 29, 2011 Sponsor/Collaborators and Study Status
4 May 4, 2012 Study Status
5 September 19, 2012 Study Status
6 October 8, 2012 Study Status and Eligibility
7 March 29, 2013 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions, Outcome Measures, Study Design, Conditions and Oversight
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Study NCT01190657
Submitted Date:  August 26, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: P216
Brief Title: Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2010
Overall Status: Recruiting
Study Start: May 2010
Primary Completion: December 2011 [Anticipated]
Study Completion: December 2011 [Anticipated]
First Submitted: August 26, 2010
First Submitted that
Met QC Criteria:
August 26, 2010
First Posted: August 27, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 26, 2010
Last Update Posted: August 27, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Eisai Limited
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a self-controlled, open, multiple-center clinical trial.
Detailed Description:
Open or close this module Conditions
Conditions: Acute Gastritis
Gastric Ulcer
Keywords: Teprenone
safety
efficacy
acute gastric lesion of chronic gastritis with acute exacerbation or gastric ulcer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 1200 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Endoscopic results of ulcer lesion:Heal rate= (healed cases + significant improved cases)/total cases administered ×100 %
[ Time Frame: 56 days ]

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

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

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 nonsteriodal 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
Open or close this module Contacts/Locations
Central Contact Person: Yaozong Yuan
Telephone: 021-68825611
Email: yuanyaozong@163.com
Study Officials: Yaozong Yuan
Principal Investigator
Ruijin Hospital
Locations: China, Shanghai
Shanghai Ruijin Hospital
[Recruiting]
Shanghai, Shanghai, China
Contact:Contact: Yaozong Yuan
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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