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

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ClinicalTrials.gov Identifier: NCT00153660
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 2, 2017
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

Brief Summary:
The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer bleeding.

Condition or disease Intervention/treatment Phase
Arthritis Cardiovascular Diseases Cerebrovascular Disorders Drug: Celecoxib(drug) Drug: Naproxen(drug) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Comparison of Celecoxib Plus Esomeprazole Versus Naproxen Plus Esomeprazole for Prevention of Recurrent Ulcer Bleeding in Patients With Arthritis and Cardiothrombotic Diseases (NSAID#8 Study)
Study Start Date : June 2005
Primary Completion Date : November 2014
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Bleeding
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Recurrent ulcer bleeding within 18 months according to pre-specified criteria [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. patients' global assessment of arthritis [ Time Frame: 18 months ]
  2. major CV events according to the Antithrombotic Trialists' criteria [ Time Frame: 18 months ]
  3. non-fatal myocardial infarction [ Time Frame: 18 months ]
  4. non-fatal stroke [ Time Frame: 18 months ]
  5. death from a vascular cause [ Time Frame: 18 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. age >18,
  2. a history of endoscopically proven gastroduodenal ulcer bleeding,
  3. H. pylori negative
  4. a history of cardiothrombotic disease requiring ASA, and
  5. anticipated regular use of NSAIDs for the duration of trial

Exclusion Criteria:

  1. concomitant use of anticoagulants;
  2. a history of gastric or duodenal surgery other than a patch repair;
  3. the presence of erosive esophagitis,
  4. gastric outlet obstruction,
  5. renal failure (defined by a serum creatinine level of more than 200 umol/L),
  6. pregnancy,
  7. terminal illness, or
  8. cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00153660     History of Changes
Other Study ID Numbers: 8N Study
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebrovascular Disorders
Joint Diseases
Musculoskeletal Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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