| CTRI Number |
CTRI/2010/091/000053 [Registered on: 22/02/2010] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
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. |
Scientific Title of Study
Modification(s)
|
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 |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower Satellite Cross Roads Ahmedabad GUJARAT 380015 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M M Prabhakar |
B.J. Medical College & New Civil Hospital, Ahmedabad |
Dept. of Orthopaedics,B.J. Medical College & New Civil Hospital-380016
Ahmadabad
GUJARAT |
079-22683721
drhimanshupanchal@gmail.com |
| Dr. Arun Vaishy |
Dr. S.N. Medical College, Jodhpur |
Dept. of Orthopaedics,Dr. S.N. Medical College-
Jodhpur
RAJASTHAN |
monavaishy@yahoo.co.in |
| Dr. Ashok Khandaka |
Mahatma Gandhi National Institute of Medical Sciences, Jaipur |
Dept. of Orthopaedics,Mahatma Gandhi National Institute of Medical Sciences-
Jaipur
RAJASTHAN |
drkhandaka@gmail.com |
| Dr. Yatin J. Desai |
N. H. L. Municipal Medical College and Sheth V. S. General Hospital, Ahmedabad |
Dept. of Orthopaedics,N. H. L. Municipal Medical College and Sheth V. S. General Hospital-
Ahmadabad
GUJARAT |
|
| Dr. Rajiv Daveshwar |
S.S.G. Hospital, Vadodara |
Dept. of Orthopedics,S.S.G. Hospital-390008
Vadodara
GUJARAT |
|
| Dr. Bhavik Dalal |
Smt. Shardaben Charitable Municipal General Hospital, Ahmedabad. |
Dept. of Orthopaedics,Smt. Shardaben Charitable Municipal General Hospital-
Ahmadabad
GUJARAT |
drbhavik2006@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Committee - Mahatma Gandhi Medical College & Hospital, Jaipur DrAshokKhandaka |
Approved |
| Institutional Ethical Committee - Dr. S. N. Medical College & Associated Group of Hospitals, Jodhpur DrArunVaishy |
Approved |
| Institutional Ethics Committee - B.J. Medical College & Civil Hospital, Ahmedabad DrMMPrabhakar |
Approved |
| Institutional Ethics Committee - Sheth V.S. General Hospital & Sheth Chinai Maternity Hospital, Ahmedabad DrYatinDesai |
Approved |
| Institutional Ethics Committee - Smt. N. H. L. Municipal Medical College, Ahmedabad DrBhavikDalal |
Approved |
| Institutional Ethics Committee for Human Research - Medical College & S.S.G. Hospital, Vadodara DrRajivDaveshwar |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, Osteoarthritis of knee and/or hip joints, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination capsule of Celecoxib 100 mg and Diacerein 50 mg |
Twice in a day for 4 weeks |
| Comparator Agent |
Fixed dose combination tablet of Aceclofenac 100 mg and Diacerein 50 mg |
Twice in a day for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
(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).
(3)The investigators? global assessment of efficacy at the end of the study |
1,2,3 & 4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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).. |