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)
Sponsor study identifier
interventional
514
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 7, 2005
Actual (reported)September 12, 2005
Actual (reported)November 2014
Actual (reported)December 2016
Actual (reported)Recurrent ulcer bleeding within 18 months according to pre-specified criteria
18 months
patients' global assessment of arthritis
18 months
major CV events according to the Antithrombotic Trialists' criteria
18 months
non-fatal myocardial infarction
18 months
non-fatal stroke
18 months
death from a vascular cause
18 months
Celecoxib and Naproxen Placebo
Naproxen and Celecoxib Placebo
Endoscopy Center, Prince of Wales Hospital
Shatin, Hong Kong, China
Chan FKL, Ching JYL, Tse YK, Lam K, Wong GLH, Ng SC, Lee V, Au KWL, Cheong PK, Suen BY, Chan H, Kee KM, Lo A, Wong VWS, Wu JCY, Kyaw MH. Gastrointestinal safety of celecoxib versus naproxen in patients with cardiothrombotic diseases and arthritis after upper gastrointestinal bleeding (CONCERN): an industry-independent, double-blind, double-dummy, randomised trial. Lancet. 2017 Jun 17;389(10087):2375-2382. doi: 10.1016/S0140-6736(17)30981-9. Epub 2017 Apr 11.
Francis K Chan, MD
Chinese University of Hong Kong
514 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis
Contact the study team to confirm eligibility.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
January 2, 2017
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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