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

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

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Key information

Conditions

Dyspepsia Chronic Gastritis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rebamipide

Drug

Rebamipide 100 mg tid for 28 days

Primary outcomes

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)

Secondary outcomes

To confirm the improvement of dyspepsia syndrome

Time frame: 3 times (at day-0, day-7 and day-28)

Sponsors and collaborators

Lead sponsor

PT Otsuka Indonesia

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Oct 16, 2009
Registry last updated: May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed