Anti Free Radical & Anti Inflammatory Effect & Safety of... | NCT00996788

Studies
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

NCT00996788

Sponsor

PT Otsuka Indonesia

Status

Completed

Last Update Posted

May 15, 2013Estimated

Enrollment

55Actual

Phase

Phase 3

Conditions

Dyspepsia
Chronic Gastritis

Interventions

Rebamipide

Countries

Indonesia

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

May 2013

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

Oct 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Oct 15, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

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

May 14, 2013

Last Update Posted Date

May 15, 2013Estimated

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rebamipide	Experimental	Rebamipide 100 mg tid for 28 days	Drug: Rebamipide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rebamipide	Drug	Rebamipide 100 mg tid for 28 days	Rebamipide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation		2 times (at day-0 and day-28)

Secondary Outcomes

Measure	Description	Time Frame
To confirm the improvement of dyspepsia syndrome		3 times (at day-0, day-7 and day-28)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who

are 18 - 80 years old
have symptoms of dyspepsia that need endoscopic examination
are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
are able to give informed concern

Exclusion Criteria:

Patients who

are treated with drugs that induce gastritis/ulcer, such as: NSAID
are chronic alcoholism,
are drug abuser
are contraindicated for endoscopy examination
has erosive or ulcerative esophagitis
has peptic ulcer that has been confirmed by endoscopy
has pyloric stenosis
has active gastrointestinal bleeding
has major absorption disorder
has history of gastric surgery
with renal disorder (creatinine > 2 mg/dL)
with liver disease ( SGOT, SGPT, bilirubin)
have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
are suffering from congestive gastropathy due cirrhosis
are suffering from congestive heart disease
are pregnant or giving breast feeding
are hypersensitive to Rebamipide
are treated with gastroprotective drugs such as : teprenone, sucralfate.
are treated with acid suppressing medicine (H2A, PPI)
are treated with antibiotics, mesalazine (Salofalk)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aziz Rani, MD	Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia		Jakarta			Indonesia

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms