Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Lequesne's algofunctional index
研究概览
简要总结
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
详细描述
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.
Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.
Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.
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
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiographic OA according to the criteria of the American College of Rheumatology;
- •morning joint stiffness between 15 and 30 minutes;
- •pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
- •normal liver and kidney function tests;
- •serum CRP levels < 10 mg/l
排除标准
- •previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
- •crystal deposition diseases
- •known hereditary or congenital defects
- •clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
- •intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)
结局指标
主要结局
Lequesne's algofunctional index
Biomarkers of joint metabolism
次要结局
- Safety and tolerance