NCT02393430

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2012

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

November 23, 2014

Last Update Submit

March 15, 2015

Conditions

Gastritis

Outcome Measures

Primary Outcomes (2)

  • modified Lanza score

    26 weeks

  • visual Analog scale

    to describe the inflamamtory of gastric mucosa pathologically

    26 weeks

Study Arms (2)

experimental

EXPERIMENTAL

The experimental group were treated with rebamipide 0.1g tid and optimization of life style.

Drug: RebamipideBehavioral: optimization of life style

control

PLACEBO COMPARATOR

The control group were only optimized their life style.

Behavioral: optimization of life style

Interventions

RebamipideDRUG

Rebamipide is a

Also known as: Mucosta
experimental
optimization of life styleBEHAVIORAL
controlexperimental

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastritis

Interventions

rebamipide

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Wang Bang-mao

    Tianjin meidcal university general hospital,China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Gastroenterology Department

Study Record Dates

First Submitted

November 23, 2014

First Posted

March 19, 2015

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03