EUCTR2007-003016-60-DK进行中(未招募)不适用
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects with Knee Osteoarthritis.
ordic Bioscience A/S0 个研究点目标入组 920 人开始时间: 2007年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 920
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
- •Ambulatory men and women with knee osteoarthritis, between 51 and 80 years old, in general good health.
- •Are the trial subjects under 18? no
- •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
- •Any disease or medication affecting the bone or cartilage metabolism (osteoporosis is allowed).
- •Conditions causing secondary osteoarthritis of the study joint
- •Obese study subjects with unilateral aggressive progressing knee OA.
- •Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.
- •Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurologic, cardiovascular, metabolic, hematological or psychiatric condition, which in the Investigator’s opinion would preclude the participant from adhering to the Protocol or completing the trial.
- •Diagnostic arthroscopy with a surgical procedure within 6 moths prior to the screening or plan to have a surgery during the clinical trial.
- •History of drug abuse or active alcoholism.
- •Any investigational drug(s) within 30 days prior to screening.
研究者
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