Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

Condition(s) targeted: Arthritis; Cardiovascular Diseases; Cerebrovascular Disorders

Intervention: Celecoxib(drug) (Drug); Naproxen(drug) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
Francis K Chan, MD, Principal Investigator, Affiliation: Chinese University of Hong Kong

Overall contact:
Francis K Chan, MD, Phone: 85226323143, Email: fklchan@cuhk.edu.hk

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.

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)

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

Primary outcome: Recurrent ulcer bleeding within 78 weeks according to pre-specified criteria

Secondary outcome: Cardiovascular events

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Francis K Chan, MD, Phone: 85226323143, Email: fklchan@cuhk.edu.hk

Endoscopy Center, Prince of Wales Hospital, Hong Kong, China; Recruiting
Franics K Chan, MD, Phone: 26323143, Email: fklchan@cuhk.edu.hk
Jessica Y Ching, MPH, Phone: 26323524, Email: jessicaching@cuhk.edu.hk
Vincent W Wong, MD, Sub-Investigator
Francis K Chan, MD, Principal Investigator

Starting date: June 2005
Last updated: March 14, 2008