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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong Identifier:
First received: September 7, 2005
Last updated: February 28, 2013
Last verified: February 2013
The aim 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 with a history of ulcer. The investigators hypothesized that among patients with a history of ulcer bleeding who receive prophylaxis with a PPI, celecoxib would be superior to naproxen for the prevention of recurrent ulcer bleeding irrespective of concomitant use of aspirin.

Condition Intervention Phase
Cardiovascular Diseases
Cerebrovascular Disorders
Drug: Celecoxib(drug)
Drug: Naproxen(drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Comparison of Esomeprazole Plus Celecoxib Versus Esomeprazole Plus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients (NSAID#8 Study)

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Recurrent ulcer bleeding within 78 weeks according to pre-specified criteria [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular events [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: June 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NSAID #1
Celecoxib and Naproxen Placebo
Drug: Celecoxib(drug)
Celecoxib 100 mg bd
Other Name: Celebrex
Active Comparator: NSAID #2
Naproxen and Celecoxib Placebo
Drug: Naproxen(drug)
Naproxen 500 mg bd
Other Name: Naprosyn

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00153660

China, Hong Kong
Endoscopy Center, Prince of Wales Hospital
Shatin, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong
  More Information

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong Identifier: NCT00153660     History of Changes
Other Study ID Numbers: 8N Study 
Study First Received: September 7, 2005
Last Updated: February 28, 2013
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebrovascular Disorders
Joint Diseases
Musculoskeletal Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors processed this record on December 07, 2016