Back to resultsClinical Effect of Rebamipide on Chronic Gastritis
Primary Purpose
Gastritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rebamipide
optimization of life style
Sponsored by
About this trial
This is an interventional treatment trial for Gastritis
Eligibility Criteria
Inclusion Criteria:
- With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
- diagnosed as chronic gastritis with endoscopic and pathological methods
- agree to join in this clinical trail
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental
control
Arm Description
The experimental group were treated with rebamipide 0.1g tid and optimization of life style.
The control group were only optimized their life style.
Outcomes
Primary Outcome Measures
modified Lanza score
visual Analog scale
to describe the inflamamtory of gastric mucosa pathologically
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02393430
Brief Title
Clinical Effect of Rebamipide on Chronic Gastritis
Official Title
Clinical Effect of Rebamipide on Chronic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
BangMao Wang
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
The experimental group were treated with rebamipide 0.1g tid and optimization of life style.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
The control group were only optimized their life style.
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Other Intervention Name(s)
Mucosta
Intervention Description
Rebamipide is a
Intervention Type
Behavioral
Intervention Name(s)
optimization of life style
Primary Outcome Measure Information:
Title
modified Lanza score
Time Frame
26 weeks
Title
visual Analog scale
Description
to describe the inflamamtory of gastric mucosa pathologically
Time Frame
26 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
diagnosed as chronic gastritis with endoscopic and pathological methods
agree to join in this clinical trail
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Bang-mao
Organizational Affiliation
Tianjin meidcal university general hospital,China
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of Rebamipide on Chronic Gastritis
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