A clinical trial to study the effects of two drugs, fixed dose combination capsules of Celecoxib and Diacerein and fixed dose combination tablets of Aceclofenac and Diacerein in patients with osteoarthritis of knee and/or hip joints.
- Conditions
- Health Condition 1: M169- Osteoarthritis of hip, unspecifiedHealth Condition 2: null- Osteoarthritis of knee and/or hip jointsHealth Condition 3: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2010/091/000053
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).Timepoint: 1,2,3 & 4 weeks
- Secondary Outcome Measures
Name Time Method (1)The degree of improvement in the Physical function of SAS questionnaire on a Visual Analogue Scale <br/ ><br>(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). <br/ ><br>(3)The investigators? global assessment of efficacy at the end of the studyTimepoint: 1,2,3 & 4 weeks