Open Label Randomized Study for Evaluating Efficacy and Safety of Ketorolac Tromethamine and Ketoprofen in Gel in Patients With Gonarthrosis and Low Back Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Change in pain on visual analogue scale (VAS) from baseline
研究概览
简要总结
Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with Gonarthrosis and Low back pain.
详细描述
This is a Comparative evaluation of therapeutic efficacy and safety of use of drug Ketorolac tromethamine gel and drug Ketoprofen gel , as an agent of local symptomatic therapy in patients with diseases of musculoskeletal system with associated pain syndrome in outpatient conditions.
The study includes patients with moderate pain syndrome in gonarthrosis and lower back pain (LBP).
The sample size of 240 was calculated for the main efficacy variable - mean pain intensity according to the visual analogue scale (VAS) in 10 days of therapy.
Patients who subjected to inclusion into the study and had signed informed consent will be distributed into the study groups depending on established diagnosis: Gonarthrosis group and LBP group.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Feedback on Informed Consent Form signed by the patient for participation in the Study.
- •Continuation of participation in the study is in conflict with the patient's interests.
- •Occurrence of a serious adverse event in the patient, the relation of which to the administration of the drug under study is classified definite, probable or possible.
- •Patient needs additional treatment which may affect the parameters of efficacy under study.
- •Violations of the protocol, which in the opinion of the investigator or sponsor of the study, are significant for evaluation of results of the clinical trial.
- •Discontinuation of the study by the sponsor.
- •Discontinuation of the study by the investigator.
- •Discontinuation of the study by the regulatory bodies.
研究组 & 干预措施
Ketorolac Tromethamine
Ketorolac 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days
干预措施: Ketorolac Tromethamine (Drug)
Ketoprofen
Ketoprofen gel 2.5% for external application. Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
干预措施: Ketoprofen (Drug)
结局指标
主要结局
Change in pain on visual analogue scale (VAS) from baseline
时间窗: 10 days
次要结局
未报告次要终点