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

Cardiovascular Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153660
• Other study ID #: 8N Study
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: December 30, 2016
• Start date: June 2005
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: December 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Cardiovascular Diseases
• Cerebrovascular Disorders

Intervention

Drug:
• Celecoxib(drug)
Celecoxib 100 mg bd
• Naproxen(drug)
Naproxen 500 mg bd

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Shatin	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent ulcer bleeding within 18 months according to pre-specified criteria		18 months	No
Secondary	patients' global assessment of arthritis		18 months	No
Secondary	major CV events according to the Antithrombotic Trialists' criteria		18 months	Yes
Secondary	non-fatal myocardial infarction		18 months	Yes
Secondary	non-fatal stroke		18 months	Yes
Secondary	death from a vascular cause		18 months	Yes