CTRI/2011/07/001926已完成3 期
A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK‑0663/Etoricoxib in Patients With Rheumatoid Arthritis - Nil
Merck Sharp and Dohme0 个研究点目标入组 1,776 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,776
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 for this study.
- •Is in general good health (other than RA);
- •Has an ACR Functional Class I, II, or III;
- •Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed;
- •Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level
排除标准
- •There is no maximum age for this study.
- •Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy;
- •Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery;
- •Has active gastric ulcer or history of inflammatory bowel disease;
- •Had undergone coronary artery bypass graft surgery (CABG), angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease;
- •Class II-IV congestive heart failure;
- •Has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix);
- •Is allergic to etoricoxib, history of a significant clinical or laboratory adverse experience associated with etoricoxib hypersensitivity to aspirin or NSAIDs or allergy to acetaminophen/paracetamol;
- •Has a personal or family history of an inherited or acquired bleeding disorder;
- •Is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence;
- •Is morbidly obese (defined as body mass index greater than or equal to 40 kg/m2);
- •Is pregnant or breast feeding
研究者
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