Preventing Recurrent Ulcer Bleeding in Arthritis Patients Using Esomeprazole Plus Celecoxib

October 26, 2006 updated by: Chinese University of Hong Kong

A Phase 3 Double Blinded, Randomized, Placebo Controlled Trial of Proton Pump Inhibitor for the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

273

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ulcer rebleeding over period of 13 months

Secondary Outcome Measures

Outcome Measure
stroke or cardio-vascular events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

October 27, 2006

Last Update Submitted That Met QC Criteria

October 26, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7NB study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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