Status:
COMPLETED
Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Arthritis
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 b...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT00153660
Start Date
June 1 2005
End Date
December 1 2016
Last Update
January 2 2017
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Shatin, Hong Kong, China