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Completed

NCT Number: NCT00153660

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endoscopy Center, Prince of Wales Hospital

Shatin, Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Celecoxib(drug)

Drug

Celecoxib 100 mg bd

Other names: Celebrex

Naproxen(drug)

Drug

Naproxen 500 mg bd

Other names: Naprosyn

Primary outcomes

  1. Recurrent ulcer bleeding within 18 months according to pre-specified criteria

    Time frame: 18 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2014
Study completion
2016
First posted
Sep 12, 2005
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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