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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00153660 |
The purpose of this study is to compare a PPI (esomeprazole) plus a COX-2 inhibitor (celecoxib) with a PPI plus a nonselective NSAID (naproxen) in preventing recurrent ulcer bleeding in arthritis patients who receive concomitant low-dose aspirin.
Condition | Intervention |
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Arthritis Cardiovascular Diseases Cerebrovascular Disorders |
Drug: Celecoxib(drug) Drug: Naproxen(drug) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Phase III Study of a Double-Blind Randomized Comparison of Esomeprazole Plus Celecoxib Versus Esomeprazole Plus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients Receiving Concomitant Low-Dose Aspirin (NSAID#8 Study) |
Estimated Enrollment: | 322 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Celecoxib
|
Drug: Celecoxib(drug)
Celecoxib 100 mg bd
|
2: Active Comparator
Naproxen
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Drug: Naproxen(drug)
Naproxen 500 mg bd
|
Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly consumed drugs worldwide for the relief of pain and arthritis. However, the use of NSAIDs increases the risk of ulcer bleeding by 4-fold. Current evidence indicates that combination of conventional NSAIDs and a proton pump inhibitor (PPI) reduces the risk of ulcer complications. The alternative strategy is to replace conventional, non-selective NSAIDs with NSAIDs selective for cyclooxygenase-2 (COX-2 inhibitors). Recently, there are concerns about the cardiovascular safety of COX-2 inhibitors and conventional NSAIDs. Because of such concern, patients requiring anti-inflammatory analgesics who have cardiovascular risk factors (e.g. smoking, hypertension, hyperlipidemia, diabetes) should receive prophylactic low-dose aspirin. However, concomitant low-dose aspirin negates the gastric sparing effect of COX-2 inhibitors and augments the gastric toxicity of nonselective NSAIDs. Thus, gastroprotective agents such as PPIs should be co-prescribed to patients with high ulcer risk who are taking aspirin plus a COX-2 inhibitor or a nonselective NSAID.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francis K Chan, MD | 85226323143 | fklchan@cuhk.edu.hk |
Contact: Jessica Y Ching, MPH | 85226323524 | jessicaching@cuhk.edu.hk |
China | |
Endoscopy Center, Prince of Wales Hospital | Recruiting |
Hong Kong, China | |
Contact: Franics K Chan, MD 26323143 fklchan@cuhk.edu.hk | |
Contact: Jessica Y Ching, MPH 26323524 jessicaching@cuhk.edu.hk | |
Sub-Investigator: Vincent W Wong, MD | |
Principal Investigator: Francis K Chan, MD |
Principal Investigator: | Francis K Chan, MD | Chinese University of Hong Kong |
Responsible Party: | Chinese University of Hong Kong ( Francis K CHAN ) |
Study ID Numbers: | 8N Study |
Study First Received: | September 7, 2005 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00153660 History of Changes |
Health Authority: | Hong Kong: Department of Health |
Anti-Inflammatory Agents Celecoxib Naproxen Ulcer Joint Diseases Cyclooxygenase Inhibitors Vascular Diseases Omeprazole Central Nervous System Diseases Hemorrhage Brain Diseases |
Cerebrovascular Disorders Recurrence Musculoskeletal Diseases Aspirin Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Brain Diseases Cerebrovascular Disorders Gout Suppressants Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics |
Celecoxib Naproxen Joint Diseases Nervous System Diseases Cyclooxygenase Inhibitors Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |