Status:
COMPLETED
Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Arthritis
Bleeding Ulcer
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effect of Esomeparzole with Placebo in the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor
Detailed Description
Among patients with previous ulcer bleeding, neither nonsteroidal anti-inflammatory drugs (NSAIDs) plus a proton pump inhibitor (PPI) nor a cyclooxygenase (COX)-2 inhibitor adequately prevents recurre...
Eligibility Criteria
Inclusion
- The inclusion criteria were ulcer healing confirmed by follow-up endoscopy, a negative test for Helicobacter pylori or successful eradication of Helicobacter pylori based on histology, and anticipated regular use of NSAIDs for the duration of the trial. The exclusion criteria were concomitant use of low-dose aspirin, anticoagulants or corticosteroids; 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 2.26 mg per deciliter), terminal illness, or cancer.
Exclusion
- The exclusion criteria were concomitant use of low-dose aspirin, anticoagulants or corticosteroids; 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 2.26 mg per deciliter), terminal illness, or cancer.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00365313
Start Date
August 1 2002
End Date
June 1 2005
Last Update
October 27 2006
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China