CTRI/2010/091/000053已完成3 期
A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Fixed dose combination capsules of Celecoxib and Diacerein in comparison with Fixed dose combination tablets of Aceclofenac and Diacerein in patients suffering from osteoarthritis of knee and/or hip joints
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- The degree of improvement in the Pain aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0).
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed dose combination capsules of Celecoxib & Diacerein and fixed dose combination tablets of Aceclofenac & Diacerein given twice a day for 4 weeks in 200 patients with osteoarthritis of knee and/or hip joints that will be conducted in three centers in India. The degree of improvement in the Pain aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0)..
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of 18 to 60 years of age.
- •2.Patients with an established diagnosis of osteoarthritis of knee and/or hip joints with at least moderate pain [at least 5 on the Visual Analogue Scale of 0 to 10 in Short Arthritis Assessment Scale (0 being no pain and 10 being severe pain)] at the affected site at the time of enrollment into the study.
- •3.Informed consent of the patient/relative/legal representative.
排除标准
- •1.Pregnancy & lactation.2.Patients with hypersensitivity to Celecoxib, Aceclofenac, any other NSAIDs, Diacerein, anthraquinone derivatives or sulfonamides.3.Patients with hepatic and / or renal insufficiency.4.Patients with active peptic ulceration within the last 6 months.5.Patients suffering from coronary heart disease or any other significant cardiovascular disorder.6.Patients suffering from any hemorrhagic diasthesis.
- •7.Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs.8.Patients with any other serious concurrent illness or malignancy.9.Patients with continuing history of alcohol and / or drug abuse.10.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of improvement in the Pain aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0).
时间窗: 1,2,3 & 4 weeks
次要结局
- (1)The degree of improvement in the Physical function of SAS questionnaire on a Visual Analogue Scale((2)The degree of improvement in the Overall well-being aspect of SAS questionnaire on a Visual Analogue Scale of 0 to 10 at the end of therapy (i.e. Week 4) and at each follow-up visit as compared to baseline (i.e. Week 0).)
研究者
研究点 (6)
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