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

A Double-blind Randomized Comparison of Celecoxib Plus Esomeprazole Versus Naproxen Plus Esomeprazole for Prevention of Recurrent Ulcer Bleeding in Patients With Arthritis and Cardiothrombotic Diseases (NSAID#8 Study)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00153660
Enrollment
514
Registered
2005-09-12
Start date
2005-06-30
Completion date
2016-12-31
Last updated
2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Cardiovascular Diseases, Cerebrovascular Disorders

Brief 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.

Detailed 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.

Interventions

DRUGCelecoxib(drug)

Celecoxib 100 mg bd

DRUGNaproxen(drug)

Naproxen 500 mg bd

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 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

Design outcomes

Primary

MeasureTime frame
Recurrent ulcer bleeding within 18 months according to pre-specified criteria18 months

Secondary

MeasureTime frame
patients' global assessment of arthritis18 months
major CV events according to the Antithrombotic Trialists' criteria18 months
non-fatal myocardial infarction18 months
non-fatal stroke18 months
death from a vascular cause18 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026