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

Cadila Healthcare Ltd6 sites in 1 country200 target enrollmentStarted: January 25, 2010Last updated: November 13, 2018

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Cadila Healthcare Ltd
Enrollment: 200
Locations: 6
Primary Endpoint: 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).

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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)..

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Open Label

Eligibility Criteria

Ages: 18.00 Year(s) to 60.00 Year(s) (—)
Sex: All

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.

Outcomes

Primary Outcomes

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).

Time Frame: 1,2,3 & 4 weeks

Secondary Outcomes

(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).)

Investigators

Sponsor

Cadila Healthcare Ltd

Sponsor Class

Pharmaceutical industry-Indian

Study Sites (6)

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