Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy
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Purpose
Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale. Third objective: To compare the proportion of patients with positive treatment effects as determined by Modified Lanza scoring between the two groups.
| Condition | Intervention | Phase |
|---|---|---|
|
NSAID Induced Gastropathy |
Drug: Rebamipide and Esomeprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy |
- To determine the levels of MDA and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Rebamipide 100mg TID for 12 weeks
|
Drug: Rebamipide and Esomeprazole
|
|
Active Comparator: 2
Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks
|
Drug: Rebamipide and Esomeprazole
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients with rheumatoid arthritis and osteoarthritis who developed dyspeptic symptoms while on NSAID for at leat 4 weeks who fulfill any of the following criteria: 1) Have not been on NSAIDs (NSAID-naïve) as they are newly diagnosed patients or satisfies ALL of the following criteria: a) Have not received NSAIDs for more than 2 years continuously, b) Have not received NSAID for at least 3 months, c) Does not take more than the therapeutic dose required for any of the following NSAIDS: Aspirin (at max. 4000mg.day), Naproxen (at max. 1375mg/day), Ibupropen (at max. 2400mg/day), Diclofenac (at max. 200mg/day), Piroxicam (at max. 40mg/day). 2) Gastric mucosal lesions on upper endoscopy (Lanza score ≥ 1) 3) More than 18 and less than 65 years old 4) Medically cleared and consents to undergo upper endoscopy 5) Willing to participate in the trial and sign an informed consent form
Exclusion Criteria:
1. Patients with known malignancy 2) Women who are pregnant and breastfeeding 3) Psychiatric illness 4) severe co-morbid illness like renal failure, cirrhosis, etc. 5) History of intake of any anti-secretory agent for the past 2 weeks 6) Patients with coagulation disorders and hematologic problems 7) Complicated ulcers, i.e. bleeding, perforating, etc. 8) Patients with evidence of portal hypertension i.e. varices, portal gastropathy, etc. 9) History of gastric surgery 10) Patients on COX-2 inhibitors 11) Modified Lanza score of 0 12) Herbal medications or complementary alternative medicines (e.g. glucosamine chondroitisulfate, etc. 13) (+)H.pylori test by RUT (Rapid Urease Test) and biopsy.
Contacts and Locations| Philippines | |
| University of Santo Tomas Hospital | |
| Manila, Philippines | |
| Veterans Memorial Medical Center | |
| Quezon City, Philippines | |
| Armed Forces of the Philippines Medical Center | |
| Quezon City, Philippines | |
| Candinal Santos medical Center | |
| San Juan City, Philippines | |
| Principal Investigator: | Jose Sollano, MD | University of Santo Tomas Hospital |
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical, Inc., Philippines |
| ClinicalTrials.gov Identifier: | NCT00641004 History of Changes |
| Other Study ID Numbers: | 037-PPB-0701i |
| Study First Received: | March 18, 2008 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Philippines: Ethics Committee/Sub-Committee on reasearch in Veterans Memorial Medical Center |
Additional relevant MeSH terms:
|
Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Anti-Inflammatory Agents, Non-Steroidal Omeprazole Rebamipide Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antioxidants Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013