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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by PT Otsuka Indonesia. Recruitment status was Recruiting

First Received on October 15, 2009. No Changes Posted

Sponsor:	PT Otsuka Indonesia
Information provided by:	PT Otsuka Indonesia
ClinicalTrials.gov Identifier:	NCT00996788

Purpose

To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.

Condition	Intervention	Phase
Dyspepsia Chronic Gastritis	Drug: Rebamipide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Rebamipide

U.S. FDA Resources

Further study details as provided by PT Otsuka Indonesia:

Primary Outcome Measures:

To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation [ Time Frame: 2 times (at day-0 and day-28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To confirm the improvement of dyspepsia syndrome [ Time Frame: 3 times (at day-0, day-7 and day-28) ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rebamipide Rebamipide 100 mg tid for 28 days	Drug: Rebamipide Rebamipide 100 mg tid for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996788

Contacts

Contact: Albertus Widjadja

6221-7827660 ext 218

albertus@ho.otsuka.co.id

Locations

Indonesia
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia	Recruiting
Jakarta, Indonesia
Principal Investigator: Aziz Rani, MD
Sub-Investigator: Marcel Simadibrata, MD
Sub-Investigator: Ari Fahrial Syam, MD
Sub-Investigator: Septelia Inawati Wanandi, MD

Sponsors and Collaborators

PT Otsuka Indonesia

Investigators

Principal Investigator:

Aziz Rani, MD

Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

More Information

No publications provided

Responsible Party:	Albertus Widjaja, Medical Director, PT Otsuka Indonesia
ClinicalTrials.gov Identifier:	NCT00996788 History of Changes
Other Study ID Numbers:	037-IOB-0701
Study First Received:	October 15, 2009
Last Updated:	October 15, 2009
Health Authority:	Indonesia: National Agency of Drug and Food Control

Keywords provided by PT Otsuka Indonesia:

Patients suffering of dyspepsia due to chronic gastritis

Additional relevant MeSH terms:

Dyspepsia
Gastritis
Gastritis, Atrophic
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents

Rebamipide
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012