CTRI/2014/03/004474 [Registered on: 13/03/2014] Trial Registered Prospectively
Last Modified On:
06/08/2014
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Clinical trial intended to compare two formulations of Diclofenac sodium topical Gel 1% along with placebo, in patients with knee osteoarthritis.
Scientific Title of Study
A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects with Osteoarthritis of the Knee
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
AM-DCG-001 version 3 dated 08-4-2013
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Andhra Medical college, Department of Orthopedics, Clinical Research division, Ground Floor, Room No. 17 and 18, Clinical Reserch Area, Unit -1 Vishakapatnam-530002, A.P, India Visakhapatnam ANDHRA PRADESH
9440608752
amcorthopaedics@hotmail.com
Dr Raja Pandian
Apollo Specialty Hospitals
Department of Orthopaedics, Room No. 65, Lake View Road, K. K. Nagar, Madurai – 625020, Tamil Nadu, India Madurai TAMIL NADU
9965528552
panvind@yahoo.co.in
Dr Rajesh Kumar Dulani
AVBR Hospital & Jawaharlal Nehru Medical College
Department of Orthopaedics, Datta Megha Instititute of Medical Sciences, Wardha, Nagpur -442004 Nagpur MAHARASHTRA
9371171000
rajeshkdulani@gmail.com
Dr Ankit Balkrishna Kedia
BJ Medical College & Civil Hospital
B.J Medical College & Civil Hospital, Department of Orthopedics, Wing 2, Ground Floor, Ahmedabad-380016 Ahmadabad GUJARAT
9879371171
ankitk@gmail.com
Dr Bartakke Girish Chandra Dyaneshwar
BJ medical college & Sassoon General Hospital
BJ Medical College Sassoon General Hospital, Dept of Orthopedics,Orthopedic Building, 2nd Floor, HOD Room, Sassoon Road, Near Railway Station, Pune - 411001 Pune MAHARASHTRA
9422036065
girishbartakke@rediffmail.com
Dr D Raj Kiran
CARE Hospitals
Department of Orthopaedics, Road No. 01, Banjara Hills, Hyderabad- 500034 Andhra Pradesh Hyderabad ANDHRA PRADESH
9849365340
docterrajkiran@gmail.com
Dr Bharath Mody
Centre for Knee and Hip Surgery
Centre for Knee & Hip Surgery, Deaprtment of Orthopaedics, Clinical Research Division, 3rd Floor, Room No. 10, Clinical Research Department, 101/103, Akashganga Building,
Near Vanijya Bhavan, Race Course Circle, Vadodara 390007, Gujarat, India
Welcare Hospital, Nera Mile Motors, Atladara, Vadodara - 390012 Vadodara GUJARAT
0265-2353670
mail@centreforkneesurgery.com
Dr Somesh Prakashbhai Singh
GMERS Medical College & Civil Hospital
Dept. of Orthopedics, Ground floor, Room No. 5, Sola, Near Gujarat High Court, S. G. Highway, Ahmedabad 380061, Gujarat. Ahmadabad GUJARAT
9825370446
drsomeshsingh@yahoo.com
Dr Samprassad S Nadkarni
Goa Medical College
Dept. Of Orthopedics, Faculty Block, Ground Floor, Goa Medical College, Bambolim, Tiswadi Goa-India, PO Box Bambolim.: 403202. North Goa GOA
9822180392
sambnadkarni@yahoo.co.in
Dr Ravindran
Government Medical College
Department of Orthopaedics, Ward No. 24, Kozhikode, Kerala 673008 Kozhikode KERALA
9447023525
raveendranmk@gmail.com
Dr Sajal R Mitra
Government Medical College and Hospital
Government Medical College and Hospital, Dept of Orthopedics, OT-E, Opp. Ward No. 26, 1st Floor Nagpur Nagpur MAHARASHTRA
9373114929
sajalmitra2007@yahoo.co.in
Dr Narendra V Kothari
Hatkesh Healthcare Foundation
Hutkesh Healthcare Foundation, Deaprtment of Orthopaedics, Clinical Research Divison, 2st Floor, Research Room, Opp. Bhutnath Temple,Junagadh, 362001 Junagadh GUJARAT
912852654652
hatkesh.research@gmail.com
Dr Alok Shobhan Datta
Institute of Post Graduate Medical Education and Research (IPGMER)
Department of Orthopedics, Ronald Ross Building, Ground Floor, # 244, AJC Bose Road, Kolkata 700020 Kolkata WEST BENGAL
9433718543
aloksobhondatta@gmail.com
Dr Smruti Ramteke
Jasleen Hospital
Jasleen Hospital,Dept. of Orthopedics, Clinical Research Division, 1st Floor, Clinical Research Room, Opp. Big Bazar, Panchashil Square, wardha Road, Nagpur-440012 Nagpur MAHARASHTRA
9823514680
sramteke@rediffmail.com
Dr Krishna Subrahmanya Kumar Pannala
Kamineni Hospitals
Department of orthopaedics, OPD room number 12, L. B. Nagar, Hyderabad-500068, Andhra Pradesh, India Hyderabad ANDHRA PRADESH
9246277646
subri_pannala@yahoo.co.in
Dr Surendra Umesh Kamath
Kasturba Medical College Hospital
Deaprtment of Orthopaedics, Ground Floor, OPD No. 12, Attavar, Mangalore – 575001, Karnataka, India Dakshina Kannada KARNATAKA
9844275231
skamath3@hotmail.com
Dr Ashok Kumar
King George Hospital
Department of Orthopedics, Unit - II, OP No. 10, King George Hospital, Andhra Medical College, Visakapatnam-530002 Visakhapatnam ANDHRA PRADESH
9849123602
Ashok_ortho59@rediffmail.com
Dr Ashish Kumar
King George Medical University
Department of Orthopedic Surgery, Lal Bahadur Shastri Bhawan, 4th Floor, Lucknow 226018 Lucknow UTTAR PRADESH
9415020202
drashish_kumar20202@yahoo.com
Dr Bhandankar
KLES Medical College
KLES Dr. Prabhakar Kore Hospital and Medical Research Center
Dept. Of Joint Replacement and Anthroscopy, Nehru Nagar, Belgaum,Karnataka – 590010
Belgaum KARNATAKA
9844131106
rajendra.bhandankar@gmail.com
Dr Veeravalli Sarath Chandra Mouli
Krishna Institute of Medical Sciences Ltd
Department of Orthopaedics, 1-8-31/1, Block 3, Room No. 1, Minister Road, Secunderabad- 500003 Hyderabad ANDHRA PRADESH
9866000685
sarath10@hotmail.com
Prof Arvind Gore Gaonkar
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Department of Orthopaedics, Department of Pharmacology, College Building, Second Floor, Room No. 2, Dr. B. R. Ambedkar Road, Sion, Mumbai - 400022 Mumbai MAHARASHTRA
9821351787
abgoregaonkar@gmail.com
Dr Naresh Shetty
M. S. Ramaiah Medical College & Hospitals
Department of Orthopaedics, MSRIT Post, New BEL Road, Bangalore – 560054 Karnataka Bangalore KARNATAKA
9844917728
naresh8@hotmail.com
Dr Kunal Bhalla
M. V. Hospital and Research Centre
Deaprtment of Orthopaedics, 314/30, Ground Floor, OP No. 2, Mirza Mandir Chowk, Lucknow -226 003 Uttar Pradesh Lucknow UTTAR PRADESH
9450903602
kunalicious_kunal@yahoo.com
Dr Rajiv Gupta
Malpani Multispeciality Hospital
Malpani Multispeciality Hospital, Department of Orthopaedics,Clinical Research Division, Basement Clinical Research Facility, SP-6, Road No-1, V.K.l Area, Sikar Road, Jaipur-302013 Jaipur RAJASTHAN
9414980697
drrajivg77@gmail.com
Dr Suresh kumar Kejriwal
Medical College & Hospital
Department of Orthopedics, Emergency building, ground floor, Room No. 6, College Street, Kolkata -700073 Kolkata WEST BENGAL
9830349698
dr_suresh01@yahoo.com
Dr Marula Siddappa
Mysore medical college
K R Hospital, Mysore Medical College & Research Institute, Department of Orthopaedics, Mysore Mysore KARNATAKA
9844319497
gmsortho@gmail.com
Dr Sushil H Mankar
NKP salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Deaprtment of Orthopaedics, 1st Floor, Digdoh Hills, Hingna road, Nagpur, Maharashtra-India Nagpur MAHARASHTRA
9422108284
drshmankar@rediffmail.com
Dr Vijay Goni
Post Graduate Institute of Medical Institute of Medical Education and Research (PGIMER)
Post Graduate Institute of Medical Education & Research (PGIMER), Dept. of Orthopedics, Ground Floor, Chandigarh-160012 , India Chandigarh CHANDIGARH
9815712727
vijaygoni@gmail.com
Dr Gaurav Jugalkishore Rathi
Rathi Hospital
Rathi Hospital, Department of Orthopaedics, Clinical Reasearch Division, Basement Clinical Research Area, Nr Anupam Shopping Centre, Opp Mahabaleshwar Soc, Nr Jodhpur Cross roads, Satellite, Ahmedabad 280 015, Gujarat, India Ahmadabad GUJARAT
9824015618
drgjrathi@yahoo.co.in
Dr Sandip Roy
RG Kar Medical College
RG Kar Medical College & Hospital,Deaprtment of Orthopaedics, Outdoor Building, Room No. 106, 1, Kshudiram Bose Sarani,
Kolkatta – 700001
Kolkata WEST BENGAL
9830048261
drskroy@hotmail.com
Dr Parag Sancheti
Sancheti Institute for Orthopaedics and Rehabilitation
Sancheti Institue for Orthopaedics and Rehabilitation, Dept. of Orthopedics, Clinical Research Division, 1st Floor, Sancheti Research Department, 16 Shivaji Nagar, Pune - 411005. Maharashtra Pune MAHARASHTRA
9822353333
parag@sanchetihospital.org
Dr Harshal Kalariya
Shree Giriraj Multispecilaity Hospital
Shree Giriraj Multispeciality Hospital, Dept. of Orthopedics, Clinical Research Division, Basement Clinical Research Facility, 150 Feet Ring Road, 27-Navjyot Park Main Road, Amin Marg Cross Road, Rajkot, Gujarat 360005 Rajkot GUJARAT
9979883331
harshalkalaria@gmail.com
Dr Neel Bhavsar
Smt NHL Municipal Medical College
Smt NHL Municipal Medical College, Department of Orthopaedics, Ortho OPD Building, Unit-A, Near Trauma Centre, Room No. 42, Ellisbridge, Ahmedabad-380006 Ahmadabad GUJARAT
9638040954
neelmb@yahoo.com
Dr Joe Joseph Cherian
St. Johns Medical College Hospital
Department of Orthopedics, 3rd Floor, Sarjapur Road, Koramangala,Banglore-560034 Bangalore KARNATAKA
9343794300
cherianjoe71@gmail.com
Dr Gurava Reddy
Sunshine hospital
Sunshine Hospitals, Department of Orthopaedics, Room No. 3, P.G. Road, Paradise, Secunderabad – 500003 Hyderabad ANDHRA PRADESH
Institutional ethics committee, Mysore Medical College & Research Institute
Approved
Institutional ethics committee, NKP salve Institute of Medical Sciences
Approved
Institutional ethics committee, PGIMER, Chandigarh-160012, India
Submittted/Under Review
Institutional ethics committee, RG Kar Medical College
Submittted/Under Review
Institutional ethics committee, Smt NHL Municipal Medical College
Submittted/Under Review
Institutional ethics committee, Sunshine hospital
Approved
Jasleen Hospitals Ethics Committee
Approved
Manipal University Ethics Committee
Approved
Rathi Ethics Committee
Approved
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Review Board
Approved
Shree Giriraj Hospital Research Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Patients with osteoarthritis of the knee ,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
1% Voltaren® Gel
Voltaren® Gel is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.Each patient will apply 1 dose of 4 gram for 4 times a day for 28 days
Intervention
Generic
Diclofenac Sodium Topical Gel
It is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (Therapeutic Equivalence Study.Each patient will apply 1 dose of 4 gram for 4 times a day for 28 days
Intervention
Vehicle (Placebo)
Vehicle (Placebo) of Diclofenac Sodium Topical Gel, 1%. Each patient will apply 1 dose of 4 gram for 4 times a day for 28 days
Inclusion Criteria
Age From
35.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1.Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
2.Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee including:
•Presence of at least three (3) of the American College of Rheumatology (ACR) criteria (age ≥ 50; stiffness lasting < 30 mins; bony tenderness; crepitus; bony enlargement; no palpable warmth)
•Symptoms for at least 6 months prior to screening, AND
•Knee (not referred) pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.), AND
•The pain in the target knee required the use of NSAIDs or paracetamol/ acetaminophen (topical or oral treatments).
3.Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
4.After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement (POM) for target knee, defined as a baseline score of ≥ 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization, AND a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization.
5.If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
6.Able to tolerate rescue medication with paracetamol/acetaminophen.
7.Willing and able to comply with the study requirements.
ExclusionCriteria
Details
1.Pregnant or lactating or planning to become pregnant during the study period.
2.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
3.History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening.
4.After discontinuing all pain medications for at least 7 days, has a baseline score of ≥ 20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
5.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
6.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
7.History of gastrointestinal bleeding or peptic ulcer disease.
8.Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
9.Elevated transaminases at screening (AST or ALT more than 2 times the upper limit of normal at screening visit).
10.Use of ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within 30 days of study randomization.
11.Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
12.Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
13.Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
15.Receipt of any drug as part of a research study within 30 days prior to screening.
16.Previous participation in this study.
17.Any use between screening and baseline of a treatment or medication that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
18.Recent history of major knee injury or surgery.
19.Known history of positive HIV.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
The primary efficacy endpoint will be the mean change from baseline to week 4 in the WOMAC pain score
Assessment of WOMAC scale from Day 1 to Day 28
Secondary Outcome
Outcome
TimePoints
not applicable
not applicable
Target Sample Size
Total Sample Size="1176" Sample Size from India="1176" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This will be randomized, multi-center, double blind, vehicle controlled, parallel group study to be performed at approximately 35 study sites located in India. The randomized subjects will be enrolled in a 1:1:1 ratio.The primary efficacy end point in the study is the mean change from baseline to week 4 in the WOMAC pain score (pain score= 0 to 20), which will be determined by the subjects responses to five questions (S1-S5) using a 5-point likert scale (i.e., none=0, mild=1, moderate=2, serve=3, extreme=4). The questions pertain to the amount of pain the subject is currently experiencing in the target knee [i.e., How much pain do you have when walking on a flat surface (S1), Going up or down stairs (S2), At night while in bed (S3), Sitting or lying (S4), Standing upright (S5)]