CTRI/2010/091/000053
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 200
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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