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Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-Induced Gastropathy
This study is currently recruiting participants.
Verified by Otsuka Pharmaceutical, Inc., Philippines, May 2008
Sponsored by: Otsuka Pharmaceutical, Inc., Philippines
Information provided by: Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier: NCT00641004
  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 IV

MedlinePlus related topics: Stomach Disorders
Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Rebamipide
U.S. FDA Resources
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

Further study details as provided by Otsuka Pharmaceutical, Inc., Philippines:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Rebamipide 100mg TID for 42 weeks
Drug: Rebamipide and Esomeprazole
  1. Rebamipide 100mg TID for 42 weeks
  2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 6 weeks
2: Active Comparator
Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 6 weeks
Drug: Rebamipide and Esomeprazole
  1. Rebamipide 100mg TID for 42 weeks
  2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641004

Contacts
Contact: Evelio Valdes +63-2-844-9266 ext 141 evaldes@otsuka.com.ph

Locations
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            
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
Investigators
Principal Investigator: Jose Sollano, MD University of Santo Tomas Hospital
  More Information

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

Study placed in the following topic categories:
Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Omeprazole
Rebamipide

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009