PER-005-99已完成未知
CLINICAL PROTOCOL FOR EFFICACY AND SAFETY STUDIES OF CELECOXIB SUCESIVE IN OSTEOARTHRITIS: SUCCESS-1
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
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
- •1. Male or female age >18 years and legal age to give consent; 2. Female patients must be postmenopausal or surgically sterilized or an analysis of pregnancy in the urine with a negative result within 7 days prior to randomization and should use an appropriate contraceptive method during the study; Nor can they meet during the breastfeeding period. 3. Clinical diagnosis of osteoarthritis of the hip or knee or the hand according to the ACR Osteoarthritis Classification Criteria (see Appendix 5) at least 6 months before randomization. 4. At the investigator´s discretion, that the patient requires and is: in conditions of undergoing a chronic treatment (daily) with an NSAID and / or with analgesics to control the symptoms of arthritis. If the patient was already taking NSAIDs, they should benefit from the treatment change. 5. Classification of the functional capacity of I-III (see Appendix 5). 6. That the patient has given written informed consent before admission to the study.
排除标准
- •1. If the patient has a history of two or more isolated episodes of active peptic ulcer, gastrointestinal hemorrhage or recurrent or duodenal ulcer.
- •2. If the patient had esophageal, gastric or duodenal ulcers within 30 days prior to randomization.
- •3. Active GI disease (eg, Crohn´s disease or ulcerative colitis) or any other disease that in the opinion of the researcher, could be an impediment to the use of an NSAID.
- •4. If the patient had any malignancy, whatever type (excluding basal cell carcinoma).
- •5. History of renal or hepatic disease of clinical importance that, in the opinion of the investigator, could be an impediment to participate in the study, for example, that in the past serum creatinine was> 2.0 mg / dL or> 177 pmol / L or that the ALT (SGPT) or the ASI (SGOT) were three times higher than the upper normal limit.
- •6. If the patient received an intraarticular or intramuscular corticosteroid or a joint injection of hyaluronic acid within 8 weeks prior to randomization.
- •7. It is anticipated that the patient may need any of the following medications during the study: a. Intra-articular or intramuscular corticosteroid or joint injection of hyaluronic acid; b. medicines for arthritis, including over-the-counter preparations, other than study medications. (Note: an aspirin <325 mg / day is allowed as a cardiac protection). c. Chronic use (daily or practically daily) of analgesics. (Note: only paracetamol or paracetamol is allowed casual, for example for the headache) d. Methotrexate, gold salts, penicillamine, antimalarials, sulfasalazine, azathioprine or ciclosporin. e. Anti-ulcer drugs, including the chronic use (daily or practically daily) of antacids. (Note: occasional use of antacids will be allowed during the study) f. Oral corticosteroids.
- •8. Known hypersensitivity to celecoxib, sulfonamides or any NSAID such as asthma, urticaria or acute rhinitis caused by aspirin or other NSAIDs.
- •9. If the patient has received any investigational medication within 30 days prior to the first dose of the study medication or if he intends to receive a research drug other than celecoxib during the course of this study.
- •10. If the patient had been previously admitted in this study.
研究者
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