Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

Last updated: December 30, 2016
Sponsor: Chinese University of Hong Kong
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Vascular Diseases

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00153660
8N Study
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer bleeding.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age >18,

  2. a history of endoscopically proven gastroduodenal ulcer bleeding,

  3. H. pylori negative

  4. a history of cardiothrombotic disease requiring ASA, and

  5. anticipated regular use of NSAIDs for the duration of trial

Exclusion

Exclusion Criteria:

  1. concomitant use of anticoagulants;

  2. a history of gastric or duodenal surgery other than a patch repair;

  3. the presence of erosive esophagitis,

  4. gastric outlet obstruction,

  5. renal failure (defined by a serum creatinine level of more than 200 umol/L),

  6. pregnancy,

  7. terminal illness, or

  8. cancer

Study Design

Total Participants: 514
Study Start date:
June 01, 2005
Estimated Completion Date:
December 31, 2016

Study Description

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.

Connect with a study center

  • Endoscopy Center, Prince of Wales Hospital

    Shatin, Hong Kong
    China

    Site Not Available

  • Endoscopy Center, Prince of Wales Hospital

    Hong Kong,
    China

    Site Not Available

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