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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Celecoxib; Naproxen

Criteria

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