Official Title: “Phase III Study of a Double-Blind Randomized Comparison of Esomeprazole Plus Celecoxib Versus Esomeprazole Plus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients Receiving Concomitant Low-Dose Aspirin (NSAID#8 Study)”

The purpose of this study is to compare a PPI (esomeprazole) plus a COX-2 inhibitor (celecoxib) with a PPI plus a nonselective NSAID (naproxen) in preventing recurrent ulcer bleeding in arthritis patients who receive concomitant low-dose aspirin.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: June 2009

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-fold. Current evidence indicates that combination of conventional NSAIDs and a proton pump inhibitor (PPI) reduces the risk of ulcer complications. The alternative strategy is to replace conventional, non-selective NSAIDs with NSAIDs selective for cyclooxygenase-2 (COX-2 inhibitors). Recently, there are concerns about the cardiovascular safety of COX-2 inhibitors and conventional NSAIDs. Because of such concern, patients requiring anti-inflammatory analgesics who have cardiovascular risk factors (e.g. smoking, hypertension, hyperlipidemia, diabetes) should receive prophylactic low-dose aspirin.

However, concomitant low-dose aspirin negates the gastric sparing effect of COX-2 inhibitors and augments the gastric toxicity of nonselective NSAIDs. Thus, gastroprotective agents such as PPIs should be co-prescribed to patients with high ulcer risk who are taking aspirin plus a COX-2 inhibitor or a nonselective NSAID.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib(drug)
  • Celecoxib 100 mg bd
• Drug: Naproxen(drug)
  • Naproxen 500 mg bd

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Celecoxib
• Active Comparator: 2
  • Naproxen

Primary Measures

• Recurrent ulcer bleeding within 78 weeks according to pre-specified criteria
  • Time Frame: 78 weeks
    

Secondary Measures

• Cardiovascular events
  • Time Frame: 78 weeks
    

Inclusion Criteria:

• Indications for prophylactic low-dose aspirin according to American Heart
• Association/American Diabetes Association guidelines
• A negative test for Helicobacter pylori or successful eradication of Helicobacter pylori according to histology
• Anticipated regular use of NSAIDs for the duration of the trial.

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chinese University of Hong Kong

Overall Clinical Trial Officials and Contacts

Francis K Chan, MD Principal Investigator Chinese University of Hong Kong  

Overall Contact: Francis K Chan, MD 85226323143 fklchan@cuhk.edu.hk

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153660

Study ID Number: 8N Study

ClinicalTrials.gov Identifier: NCT00153660

Health Authority: Hong Kong: Department of Health