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

This study is currently recruiting participants.
Verified February 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153660
First received: September 7, 2005
Last updated: February 28, 2013
Last verified: February 2013
  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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153660

Contacts
Contact: Jessica YL CHING, MPH +852 2632 3524 jessicaching@cuhk.edu.hk

Locations
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         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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 April 17, 2014