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
Arthritis Cardiovascular Diseases Cerebrovascular Disorders	Drug: Celecoxib(drug)

Further Study Details: 

Primary Outcomes: Recurrent ulcer bleeding within 52 weeks according to pre-specified criteria
Expected Total Enrollment:  322

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Indications for prophylactic low-dose aspirin according to American Heart Association/American Diabetes Association guidelines
• A negative test for Helicobacter pylori or successful eradication of Helicobacter pylori according to histology
• Anticipated regular use of NSAIDs for the duration of the trial.

Exclusion Criteria:

• Concomitant use of anticoagulants
• A history of gastric or duodenal surgery other than a patch repair
• The presence of erosive esophagitis, gastric outlet obstruction, renal failure (defined by a serum creatinine level of more than 200 umol/L)
• Pregnancy
• Terminal illness, or cancer

Please refer to this study by ClinicalTrials.gov identifier  NCT00153660

Francis K Chan, MD      85226323143    fklchan@cuhk.edu.hk
Jessica Y Ching, MPH      85226323524    jessicaching@cuhk.edu.hk

China
      Endoscopy Center, Prince of Wales Hospital, Hong Kong,  China; Recruiting

Study chairs or principal investigators

Francis K Chan, MD,  Principal Investigator,  Chinese University of Hong Kong   

Study ID Numbers:  8N Study
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153660
Health Authority: Hong Kong: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13