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Sponsored by: |
Otsuka Pharmaceutical, Inc., Philippines |
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Information provided by: | Otsuka Pharmaceutical, Inc., Philippines |
ClinicalTrials.gov Identifier: | NCT00641004 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
Official Title: | Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-Induced Gastropathy |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Rebamipide 100mg TID for 42 weeks
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Drug: Rebamipide and Esomeprazole
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2: Active Comparator
Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 6 weeks
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Drug: Rebamipide and Esomeprazole
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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.
Contact: Evelio Valdes | +63-2-844-9266 ext 141 | evaldes@otsuka.com.ph |
Philippines | |
Candinal Santos medical Center | Recruiting |
San Juan City, Philippines | |
Contact: Diana Payawal, MD | |
Principal Investigator: Diana Payawal, MD | |
Veterans Memorial Medical Center | Recruiting |
Quezon City, Philippines | |
Contact: Jaime Ignacio, MD | |
Principal Investigator: Jaime Ignacio, MD | |
Armed Forces of the Philippines Medical Center | Recruiting |
Quezon City, Philippines | |
Contact: Arsenio Caburnay, MD | |
Principal Investigator: Arsenio Caburnay, MD | |
University of Santo Tomas Hospital | Recruiting |
Manila, Philippines | |
Contact: Jose Sollano, MD | |
Principal Investigator: Jose Sollano, MD |
Principal Investigator: | Jose Sollano, MD | University of Santo Tomas Hospital |
Responsible Party: | Otsuka Pharmaceutical, Inc., Philippines ( Otsuka Pharmaceutical, Inc., Philippines ) |
Study ID Numbers: | 037-PPB-0701i |
Study First Received: | March 18, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00641004 |
Health Authority: | Philippines: Ethics Committee/Sub-Committee on reasearch in Veterans Memorial Medical Center |
Digestive System Diseases Stomach Diseases Gastrointestinal Diseases Omeprazole Rebamipide |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Protective Agents Pharmacologic Actions |