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.

Phase 3

Completed

• Conditions: Osteoarthritis of hip, unspecified, Osteoarthritis of knee and/or hip joints, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2010/091/000053
• Lead Sponsor: Cadila Healthcare Ltd

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)..

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.

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).	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	(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).

Trial Locations

Locations (6)

B.J. Medical College & New Civil Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. S.N. Medical College, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

Mahatma Gandhi National Institute of Medical Sciences, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

N. H. L. Municipal Medical College and Sheth V. S. General Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

S.S.G. Hospital, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

Smt. Shardaben Charitable Municipal General Hospital, Ahmedabad.; 🇮🇳 Ahmadabad, GUJARAT, India

B.J. Medical College & New Civil Hospital, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr M M Prabhakar

Principal investigator

079-22683721

drhimanshupanchal@gmail.com