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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,176
- 试验地点
- 9
- 主要终点
- Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
研究概览
简要总结
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 51 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical history and symptoms of knee osteoarthritis
排除标准
- •Any other disease or medication affecting the bone or cartilage.
- •Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months
干预措施: SMC021 Oral Calcitonin (Drug)
2
SMC021 Placebo, orally twice daily during 24 months
干预措施: SMC021 Placebo (Drug)
结局指标
主要结局
Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
时间窗: Change from baseline to 24 months
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
时间窗: Change from baseline to 24 months
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
时间窗: Change from baseline to 24 months
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).
次要结局
- Changes in Biochemical Markers of Bone & Cartilage Metabolism.(From Baseline to Month 24)
- Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months(Baseline and Month 24)
- Nature and # of AEs Monitored Continuously During Study(From Baseline to Month 24)
- Disease Progression in the Knee Evaluated by MRI.(From Baseline to Month 24)