Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients
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Purpose
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 |
|---|---|---|
|
Arthritis 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) |
- Recurrent ulcer bleeding within 78 weeks according to pre-specified criteria [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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| Contact: Jessica YL CHING, MPH | +852 2632 3524 | jessicaching@cuhk.edu.hk |
| China, Hong Kong | |
| Endoscopy Center, Prince of Wales Hospital | Recruiting |
| Shatin, Hong Kong, China | |
| Contact: Franics K Chan, MD +852 2632 3524 fklchan@cuhk.edu.hk | |
| Sub-Investigator: Vincent W Wong, MD | |
| Principal Investigator: Francis K Chan, MD | |
| Principal Investigator: | Francis K Chan, MD | Chinese University of Hong Kong |
More Information
No publications provided
| Responsible Party: | Francis KL Chan, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov 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:
|
Arthritis Cardiovascular Diseases Cerebrovascular Disorders Hemorrhage Joint Diseases Musculoskeletal Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Pathologic Processes Naproxen Anti-Inflammatory Agents, Non-Steroidal Celecoxib Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013