Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier:
NCT00641004
First received: March 18, 2008
Last updated: August 23, 2011
Last verified: December 2009
  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

Resource links provided by NLM:


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
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
  1. Rebamipide 100mg TID for 12 weeks
  2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks
Active Comparator: 2
Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks
Drug: Rebamipide and Esomeprazole
  1. Rebamipide 100mg TID for 12 weeks
  2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 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

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
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
Investigators
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
Rebamipide
Omeprazole
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014