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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 3

Conditions

Arthritis
Cardiovascular Diseases
Cerebrovascular Disorders

Treatments

Drug: Celecoxib(drug)
Drug: Naproxen(drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT00153660
8N Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

514 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age >18,
  • a history of endoscopically proven gastroduodenal ulcer bleeding,
  • H. pylori negative
  • a history of cardiothrombotic disease requiring ASA, and
  • anticipated regular use of NSAIDs for the duration of 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

514 participants in 2 patient groups

NSAID #1
Active Comparator group
Description:
Celecoxib and Naproxen Placebo
Treatment:
Drug: Celecoxib(drug)
NSAID #2
Active Comparator group
Description:
Naproxen and Celecoxib Placebo
Treatment:
Drug: Naproxen(drug)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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