Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib

Phase 3

Completed

• Conditions: Bleeding Ulcer; Arthritis

• Registration Number: NCT00365313
• Lead Sponsor: Chinese University of Hong Kong

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 recurrent ulcer bleeding.

The aim is to investigate whether adding a PPI to a COX-2 inhibitor is superior to a COX-2 inhibitor alone for the prevention of recurrent ulcer bleeding in high-risk patients.

Patients with arthritis who presented with NSAID-induced ulcer bleeding were eligible if they had healed ulcers on follow-up endoscopy; were H. pylori negative or eradicated; and required regular NSAIDs. After the ulcers had healed, all patients received celecoxib 200 mg b.i.d. They were randomly assigned to esomeprazole 20 mg b.i.d. or its placebo for 12 months. The primary endpoint was recurrent ulcer bleeding.

Results Intention-to-treat analysis included 273 patients (137 received esomeprazole and 136 received placebo). Recurrent ulcer bleeding occurred in none receiving esomeprazole and 8 patients receiving placebo. The 12-month cumulative incidence of recurrent bleeding was 0% in the esomeprazole group and 8.9% in the placebo group (difference, 8.9 percentage points; 95% confidence interval for the difference, 4.1 to 13.7; P=0.0004). During follow-up, 16.1% of patients in the esomeprazole group and 15.4% in the placebo group used low-dose aspirin. Among patients who did not use aspirin, the cumulative incidence of recurrent ulcer bleeding was 0% in the esomeprazole group and 7.1% in the placebo group (difference, 7.1 percentage points; 95% confidence interval, 2.4 to 11.8; P=0.004).

Conclusion Among patients with arthritis who have previous NSAID-induced ulcer bleeding, adding a PPI to a COX-2 inhibitor is superior to a COX-2 inhibitor alone for the prevention of recurrent ulcer bleeding.

Study Timeline

• Study Start: 2002-08
• Study Completion: 2005-06
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-26
• Last Update Posted: 2006-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ulcer rebleeding over period of 13 months

Secondary Outcome Measures

Name	Time	Method
stroke or cardio-vascular events

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, China