Oxaceprol versus tramadol in knee osteoarthritis: a randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effectiveness of oxaceprol in symptomatic primary osteoarthritis of the knee
研究概览
简要总结
In this study we propose to evaluate the effectiveness and safety of Oxaceprol (200 mg thrice daily orally) as analgesic in osteoarthritis of the knee in comparison to Tramadol (50 mg thrice daily orally) in a randomized single blind controlled trial design.
Study population would be patients attending Rheumatology OPD of IPGME&R & SSKM Hospital, Kolkata. Target sample size will be 50 evaluable patients in each group (assuming dropout rate 20%), suffering from primary symptomatic knee osteoarthritis. Subjects with secondary forms of osteoarthritis, history of recent invasive intervention of the knee, severe form of the disease or significant comorbidity would be excluded. After obtaining written informed consent, subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to oxaceprol or tramadol and treatment continued for 12 weeks. Interim follow-up visits would be at 4 week intervals. Patients will be assessed by WOMAC osteoarthritis index and a 5-point clinical global impression (CGI) scale. A responder rate will be calculated on basis of 50% reduction in pain score. We would also look for treatment emergent adverse events and effects on standard laboratory safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of primary symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee will be scored as the ‘signal knee’) fulfilling the following: •Age: Above 50 years •Sex: Either sex will be included •Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min OR knee crepitus •Knee pain on movement of intensity at least 35 mm on a 100 mm VAS (Visual Analogue Score) scale.
排除标准
- •â€¢Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Paget’s disease, hemophilia etc.
- •â€¢Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis etc) •Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months.
- •â€¢Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime.
- •â€¢Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year.
- •â€¢Serious concomitant disease.
- •â€¢Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrollment of a particular subject into the trial.
结局指标
主要结局
Effectiveness of oxaceprol in symptomatic primary osteoarthritis of the knee
时间窗: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week
次要结局
- Safety profile of Oxaceprol(Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week)