ISRCTN25438351已完成不适用
A double-blind, active-controlled, randomized, parallel group multicentric study to investigate the safety, tolerability and efficacy of reparagen - a dietary supplement compared to glucosamine sulphate in patients with moderate osteoarthritis of the knee
Santerra Pharmaceuticals LLC (USA)0 个研究点目标入组 80 人开始时间: 2006年6月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- 性别
- All
入选标准
- •1. Ambulatory adult patients of either sex >20 years of age
- •2. Patients with moderate osteoarthritis of the knee, clinically detected and/or diagnosed as per radiological examination and American Rhematology Association (ARA) functional classification
- •3. ARA functional class II or III
- •4. Kellgren Lawrence for knee osteoarthritis grade II, grade III
- •5. Patient's assessment of overall pain score between 40 and 100 mm on a pain-visual analogue scale after washout period
排除标准
- •1. Arthritis other than osteoarthritis
- •2. Arthroscopy of either knee in the past year
- •3. Administration of intraarticular steroids within the past three months or hyaluronic acid in the last nine months
- •4. Known adverse responses to non-steroidal anti-inflammatory drugs (NSAIDs), suspected hypersensitivity, allergy or other contraindication to any compounds present in the study medication
- •5. Significant gastrointestinal (GI) diseases or previous GI upset to NSAID administration
- •6. Pregnant or lactating women or woman of child-bearing age not following adequate contraception
- •7. Evidence of severe renal, hematopoetic disease or severe cardiac insufficiency as revealed by laboratory investigations and other tests
- •8. Moderate to severe peripheral neuropathy or other neurological disorders
- •9. Unwilling or unable to come to regular follow-up studies
- •10. Any condition which in the opinion of the investigator does not justify patient inclusion in the study
- •11. Inability to give informed consent
研究者
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