Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
1 other identifier
interventional
55
1 country
1
Brief Summary
To study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2007
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 15, 2013
May 1, 2013
4.3 years
October 15, 2009
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
To confirm the improvement of dyspepsia syndrome
3 times (at day-0, day-7 and day-28)
Study Arms (1)
Rebamipide
EXPERIMENTALRebamipide 100 mg tid for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Jakarta, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aziz Rani, MD
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 16, 2009
Study Start
October 1, 2007
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 15, 2013
Record last verified: 2013-05