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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014