PER-028-01已完成未知
An international, multicenter, stratified, randomized, double-blind, double-dummy, parallel-group, 52-week gastrointestinal clinical safety study to demonstrate that COX189 (400 mg od) reduces the risk to develop complicated ulcers as compared to NSAlDs (naproxen 500 mg bid and ibuprofen 800 mg tid), in rheumatoid arthritis and osteoarthritis patients
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2001年1月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Outpatient male or female patients, willing to cooperate, 50 years of age or older or at least 40 years old and receiving long-term glucocorticoid therapy
- •That they require therapy with NSAIDs, that is, they are currently receiving treatment with NSAIDs or whose medical condition is indicated for treatment with NSAIDs, and that treatment with NSAIDs is expected to continue for 12 months (with possible total interruptions of no more than 3 months).
- •Low daily doses of continuous aspirin (ASA) (75 mg -100 mg) are allowed for primary or secondary cardiovascular prevention.
- •With H. pylori status positive or negative: serological tests will be carried out at the end of the study.
- •Patients who have been previously recruited in any COX study189 may be included.
- •Have signed a written informed consent before any trial procedure is conducted.
排除标准
- •Patients with RA: suffering from chronic adult juvenile arthritis (ie, chronic juvenile arthritis that continued its activity in adulthood) who are taking cyclophosphamide or any alkylating agent
- •Patients with OA: secondary osteoarthritis with history and / or any evidence in the joint that is potentially chosen to be evaluated during the trial of the following diseases: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget´s disease of bone, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson´s disease, primary ostencondromatosis, hereditary disorders (eg, hypermobility), mutations of the collagen gene.
- •Other rheumatic diseases, including but not limited to, uncontrolled gout (acute gouty arthritis during the past 3 months), recurrent episodes of pseudogout (chondrocalcinosis is allowed without pseudogout symptoms), primary fibromyalgia (secondary fibromyalgia is allowed, if in the opinion of the investigator, it will not interfere with the assessment of the patient´s pain), systemic lupus erythematosus, ankylosing spondylitis, polymyositis or dermatomyositis, vasculitic syndrome, scleroderma, psoriatic arthritis, reactive arthritis, active rheumatic fever, primary Sjogren´s syndrome, mixed connective tissue and Behcet syndrome.
- •Patients who are taking any of the following gastroprotective medications with the following criteria:
- •- Proton pump inhibitors and misoprostol are excluded. Patients can not be washed out of the dose to be included in the study
- •- High doses of H-2 receptor antagonists are excluded (eg: Famotidine 40 mg or more per day or equivalent). Patients may not be subjected to high-dose H-2 receptor antagonist washout only for the purpose of entering the study. They may stop taking H-2 receptor antagonists (eg, Famotidine 20 mg or less per day or equivalent) in order to enter the study, if this is done at least 4 weeks before the screening visit. Patients who are taking antacids only for the purpose of calcium supplementation are also eligible to enter the trial, but should discontinue the intake of antacids at the screening visit.
- •- Sucralfate is excluded. However, patients may be washed from them to enter the trial. The washout period should be carried out at least 1 month before the screening visit.
- •Patients taking anticoagulants (warfarin, low molecular weight heparin) and antiplatelet agents.
- •Patients with evidence of active ulceration of the upper GI tract within the previous 30 days or bleeding from the upper gastrointestinal tract in the previous year or a history of perforations and gastroduodenal obstructions.
- •Patients who have undergone any previous gastric surgery (resection or vagotomy) except a simple ulcer suture or Nissen fundoplication for reflux.
- •Patients with a history of inflammatory bowel disease (eg, ulcerative colitis or Crohn´s disease), or tumors in the upper GI tract.
- •Patients with complicated JivciLiculosis (eg, swelling, pain or bleeding)
- •Patient with a history of hemorrhagic diathesis
- •Patients with evidence of liver disorders (ALT, AST> 1.5 x ULN), kidney disease (serum creatinine> 1.25 x ULN) or coagulation (eg haemophilia) or anemia (hemoglobin less than 20g / L below) of the normal lower limit).
- •Patients with known hypersensitivity to analgesics, antipyretics or NSAIDs.
- •Subjects with a history of cancer of any organic system, treated or not, within th
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