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

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

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

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)