Clinical Effect of Rebamipide on Chronic Gastritis | NCT02393430

Studies
Clinical Effect of Rebamipide on Chronic Gastritis

NCT02393430

Sponsor

BangMao Wang

Status

Completed

Last Update Posted

Mar 19, 2015Estimated

Enrollment

180Actual

Phase

Phase 4

Conditions

Gastritis

Interventions

Rebamipide
optimization of life style

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Nov 23, 2014

First Submission Date that Met QC Criteria

Mar 15, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2015

Last Update Posted Date

Mar 19, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

BangMao Wang, Chief of Gastroenterology Department, Tianjin Medical University General HospitalSponsor-Investigator

Lead Sponsor

BangMao WangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	Experimental	The experimental group were treated with rebamipide 0.1g tid and optimization of life style.	Drug: Rebamipide Behavioral: optimization of life style
control	Placebo Comparator	The control group were only optimized their life style.	Behavioral: optimization of life style

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rebamipide	Drug	Rebamipide is a	experimental	Mucosta

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wang Bang-mao	Tianjin meidcal university general hospital,China	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005756	Gastritis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C052785	rebamipide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided