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Clinical Effect of Rebamipide on Chronic Gastritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393430
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
BangMao Wang, Tianjin Medical University General Hospital

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
Gastritis Drug: Rebamipide Behavioral: optimization of life style Phase 4

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Study Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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 Name: Mucosta

Behavioral: optimization of life style
Placebo Comparator: control
The control group were only optimized their life style.
Behavioral: optimization of life style



Primary Outcome Measures :
  1. modified Lanza score [ Time Frame: 26 weeks ]
  2. visual Analog scale [ Time Frame: 26 weeks ]
    to describe the inflamamtory of gastric mucosa pathologically



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393430


Sponsors and Collaborators
BangMao Wang
Investigators
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Study Chair: Wang Bang-mao Tianjin meidcal university general hospital,China
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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: March 19, 2015    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors