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Clinical Effect of Rebamipide on Chronic Gastritis

Sponsor
BangMao Wang (Other)
Overall Status
Completed
CT.gov ID
NCT02393430
Collaborator
(none)
180
Enrollment
2
Arms
25
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Effect of Rebamipide on Chronic Gastritis
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. modified Lanza score [26 weeks]

    2. visual Analog scale [26 weeks]

      to describe the inflamamtory of gastric mucosa pathologically

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • BangMao Wang

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BangMao Wang, Chief of Gastroenterology Department, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT02393430
    Other Study ID Numbers:
    • GH 0123
    First Posted:
    Mar 19, 2015
    Last Update Posted:
    Mar 19, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Gastritis
    Rebamipide

    Study Results

    No Results Posted as of Mar 19, 2015