Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events

Pfizer, S.A.0 个研究点目标入组 4,402 人开始时间: 2005年10月21日最近更新: 2012年5月1日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Pfizer, S.A.
入组人数: 4,402

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Male and female subjects who meet all criteria listed below will be included in the study.
•1.Outpatient or inpatient
•2.Subjects with a clinical diagnosis of OA or RAaa
•3.Subjects who are expected to require regular anti-inflammatory therapy for arthritis symptom management
•4.Subjects must be aged = 60 years with or without a history of GD ulceration; or be of any age =18 years and have had documented in clinical notes evidence of GD ulceration 90 days or more prior to the screening visit
•The following are acceptable as documentation of a previous history of GD ulceration: investigational site clinical notes/ endoscopy or radiographic report; documentation provided by another institution or the subject’s primary care provider; verbal confirmation by another institution or the subject’s primary care provider. Verbal confirmation by the subject alone without corroboration is not sufficient. History of GD ulceration includes both uncomplicated and complicated events. Subjects who have a history of complicated ulcer disease are most at risk of the development of further serious events. In considering subjects with previous complicated ulcers for inclusion into the trial investigators must carefully weigh the balance of benefit: risk for inclusion of the subject into the trial and discuss this with the subject as per the informed consent
•5.Screening tests are negative for H pylori (serology, 13C or 14C breath test or rapid urease/histology or fecal antigen). Subjects who test positive on serology must have active infection excluded using a second methodology.
•6.Female subjects of childbearing potential must not be pregnant or lactating at screening and must have a negative urine pregnancy test at screening (women post-menopausal for <2 years will also require a urine pregnancy test at screening)
•7.Female subjects of childbearing potential must be using effective contraception since the last date of their menses and continue to do so during the study period
•8.Written informed consent obtained.
•Are the trial subjects under 18?
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Subjects presenting with any of the following will not be included in the study:
•1.GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit
•2.Current use of anticoagulant agents, lithium, disease modifying anti-rheumatic drugs (DMARDs- unless on stable dose for at least 12 weeks), corticosteroids (dose equivalent of prednisolone/ prednisone =10mg daily allowable if on stable dose for at least 12 weeks), NSAIDs, proton pump inhibitors (PPIs – other than use of study medication), sucralfate, misoprostol or regular use of a histamine-2 receptor antagonist (H2RAs; > 3 days/week). Current H2RAs use intermittently (no more than 3 days/week) for dyspepsia is allowed; antacids are allowed. Subjects receiving PPI, COX-2 specific inhibitor or NSAID therapy at the screening visit are allowable into the trial, if these treatments are discontinued at the time of screening and the other inclusion/ exclusion criteria are met.
•3.Subjects using aspirin, including low dose aspirin*
•4.Subjects using other antiplatelet agents (ticlopidine, clopidogrel, dipyridamole)
•5.Subjects with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature
•6.History of gastric or duodenal surgery other than patch repair/ over sew
•7.Presence of erosive esophagitis, gastric-outlet obstruction
•8.Malignancy or history of malignancy other than surgically removed basal cell carcinoma. Subjects with successfully treated malignancy and no history or evidence of recurrent disease within 5 years prior to enrollment may be included in the study
•9.Pregnant or lactating women, or women of childbearing potential including women less than two years post-menopausal not using an acceptable method of contraception
•10.Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
•11.Current or history of alcohol and/or any other substance abuse
•12.Previous participation in this study (subjects who fail screening due to HP infection may be considered for future enrollment in the trial if in the view of the investigator treatment for HP is deemed appropriate, is successfully eradicated, and at the time of re-screening the subject meets all inclusion/ exclusion criteria)
•13.Previous history of intolerance or hypersensitivity to diclofenac, celecoxib, omeprazole, NSAIDs, aspirin and sulfonamides (including but not limited to subjects who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions after taking aspirin or NSAIDs)
•14.Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
•15.Impaired hepatic function (SGPT (ALT) or SGOT (AST) > 1.5x upper limit of normal) or impaired renal function (serum creatinine >1.2 x upper limit of normal)
•16.Any other condition or Baseline finding which, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
•17.Anemia with Hb <11.5g/dl
•18.Suspected or clinical diagnosis of inflammatory bowel disease
•19.Congestive heart failure (NYHA class II- IV)
•20.Subjects considered to have a requirement for continued use of a PPI (for example, severe gastro-esophageal refl

研究者

发起方

Pfizer, S.A.

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