Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00365313
Study type	Interventional
Source	Chinese University of Hong Kong
Contact
Status	Completed
Phase	Phase 3
Start date	August 2002
Completion date	June 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms