CTRI/2011/07/001927已完成3 期
A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis - Nil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
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
- •There is no maximum age limit.
- •- Has a definite diagnosis of Ankylosing Spondylitis (AS) made at least 6 months prior to screening
- •- Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days
- •- Must demonstrate sufficient flare or worsening of AS pain
- •- Is in general good health (other than AS)
- •- Has had approved non-study antirheumatic therapy that has been at stable dosing AND is not anticipated to undergo a change within the first 6 weeks of the protocol.
排除标准
- •- Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis,
- •spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rhuematica, a history of septic arthritis or intra-articular fracture of the study joint, Wilsons disease, hemachromatosis, ochronosis, or primary osteochondromatosis
- •- Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis
- •- Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption
- •- Has active peptic ulcer or a history of inflammatory bowel disease
- •- Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
- •- Has Class II-IV congestive heart failure
- •- Has uncontrolled hypertension
- •- Has a history of neoplastic disease (cancer or benign tumor), except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated greater than or equal to 5 years prior to screening
- •- Has history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease
- •- Allergy to etoricoxib or naproxen, or history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen
- •- Has a history or family history of an inherited or acquired bleeding disorder
- •- Is considered morbidly obese and demonstrates significant health problems stemming from obesity, which would confound study participation or interpretation of study results
- •- Is pregnant, breast-feeding, or expecting to conceive during the study.
研究者
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