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NCT02393430 Clinical Trial

Clinical Effect of Rebamipide on Chronic Gastritis

Gastritis Clinical Trial

Official title:
Clinical Effect of Rebamipide on Chronic Gastritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02393430
Other study ID # GH 0123
Secondary ID
Status Completed
Phase Phase 4
First received November 23, 2014
Last updated March 15, 2015
Start date May 2012
Est. completion date June 2014

Study information
Verified date March 2015
Source Tianjin Medical University General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Tianjin Municipal Health Bureau
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rebamipide
Rebamipide is a
Behavioral:
• optimization of life style

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BangMao Wang

Outcome
Type Measure Description Time frame Safety issue
Primary modified Lanza score 26 weeks Yes
Primary visual Analog scale to describe the inflamamtory of gastric mucosa pathologically 26 weeks Yes
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