Clinical Effect of Rebamipide on Chronic Gastritis

March 15, 2015 updated by: BangMao Wang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
The experimental group were treated with rebamipide 0.1g tid and optimization of life style.
Drug: Rebamipide
Rebamipide is a
Other Names:
  • Mucosta
Behavioral: optimization of life style
Placebo Comparator: control
The control group were only optimized their life style.
Behavioral: optimization of life style

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Lanza score
Time Frame: 26 weeks
26 weeks
visual Analog scale
Time Frame: 26 weeks
to describe the inflamamtory of gastric mucosa pathologically
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BangMao Wang

Investigators

  • Study Chair: Wang Bang-mao, Tianjin meidcal university general hospital,China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 23, 2014

First Submitted That Met QC Criteria

March 15, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 15, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH 0123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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