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CLINICAL TRIALS PROFILE FOR EC-NAPROSYN

Clinical Trials for Ec-naprosyn

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00153660	Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients	Unknown status	Chinese University of Hong Kong	Phase 3	2005-06-01	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.
NCT00383487	A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer	Terminated	Novacea	Phase 2	2005-03-01	To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
NCT00383487	A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer	Terminated	Stanford University	Phase 2	2005-03-01	To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
NCT00527904	A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)	Completed	POZEN	Phase 3	2007-03-01	This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).
NCT00533247	Arthroplasty Inflammation Prophylaxis With Celecoxib	Unknown status	Zanbilowicz, Adam, DPM MS	N/A	1969-12-31	This double blinded, placebo controlled, study seeks to determine the efficacy of preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in post-operative pain in previous studies. However, the short duration of dosing in those studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used before surgery. This study hypothesizes that the use of celecoxib for seven days preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline search has not identified any studies into the preoperative use of an NSAID at a dosing level that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this research could lead to a new understanding of the role inflammation plays in orthopedic procedures and other elective procedures and thus improve patient outcomes in the future.
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