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CTRI Number  CTRI/2009/091/000274 [Registered on: 20/05/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to assess the efficacy and safety of topical Dexketoprofen Trometamol Gel in the treatment of knee osteoarthritis 
Scientific Title of Study   A clinical trial to assess the efficacy and safety of topical Dexketoprofen Trometamol Gel in the treatment of knee osteoarthritis 
Secondary IDs if Any  
Secondary ID  Identifier 
Emc/KO/DEXKT/01/2008  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. N. J. Karne 
Designation   
Affiliation   
Address  Pune Institute of Accident and Orthopedics

Pune
MAHARASHTRA
411037
India 
Phone  09822036724  
Fax    
Email  njkarne@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Onkar C. Swami 
Designation   
Affiliation  Manager - Medical Services 
Address  Manager - Medical Services, Emcure Pharmaceuticals Ltd, Phase I Rajiv Gandhi IT park, Hinjwadi

Pune
MAHARASHTRA
411057
India 
Phone  02039821000  
Fax  02039821019  
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Onkar C. Swami 
Designation   
Affiliation   
Address  Manager - Medical Services, Emcure Pharmaceuticals Ltd, Phase I Rajiv Gandhi IT park, Hinjwadi

Pune
MAHARASHTRA
411057
India 
Phone  02039821000  
Fax  02039821019  
Email  Onkar.Swami@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Limited, Pune. 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Limited, Pune. 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Malhar H. Dave  Abhishek orthopedic Hospital  Shivalik Complex, Shubhanpura Main Road,-390007

 


 
Dr. S. K. Singh  Apex Hospital  Apex welcare Pvt Ltd, D.L.W. HYDL Road, Varanasi ,-221004
Varanasi
UTTAR PRADESH 
542-2318716
542-2317414
md@apexhospitalvaranasi.com 
Dr Gurpreet Dhingra  Dr Gurpreet's Clinic  $ Asiya Manzil, Kishor kumar ganguly marg juhu tara raod Santacruz (W) ,-400049
Mumbai
MAHARASHTRA 


 
Dr Hemal Mehta  Dr Hemal Mehta  Ground Floor, Vireshwar Kunj, Telpal road, Vile Parle (E),-400057
Mumbai
MAHARASHTRA 


 
Dr Manoj Rohara  Dr Manoj Rohara  Bhagwan Niwas, 18th Road, Near fab India Khar (W),-400052
Mumbai
MAHARASHTRA 


 
Dr. Madan S. Hardikar  Hardikar Hospital  Hardikar Hospital Pune,-
Pune
MAHARASHTRA 


madanhardikar@vsnl.net 
Dr. Anmol Maria  Orthocare  B ? 532, New Friends Colony,-110025
New Delhi
DELHI 
011-26830543

anmolmaria@gmail.com 
Dr. J. B. Panse  Panse Hospital   10/73 Agarkar Nagar, Pune,-411001
Pune
MAHARASHTRA 
020-26126524

jbpanse@vsnl.net 
Dr. N. J. Karne  Pune Institute of Accident and Orthopedics  Krishna Chembers, near Swargate Pune,-411037
Pune
MAHARASHTRA 
020-24265148

njkarne@hotmail.com 
Dr. Indraneel Basu  Ramkrishna Mission Hospital  Ramkrishna Mission Hospital, Varanasi,-
Varanasi
UTTAR PRADESH 
0542318628

dribasumd@yahoo.co.in 
Dr. Parag Sancheti  Sancheti Institute for Orhopedics & Rehabilitation  16 Shivaji Nagar Pune,-411005
Pune
MAHARASHTRA 
020-25536262
020-25530333
parag@sanchetihospital.org 
Dr Rajendra J. Khaire  Shri Guruji Rugnalaya  II floor Umiya Appartment Dr. Hedgewar chowk, Canada corner,-422005
Nashik
MAHARASHTRA 


 
Dr. Milind D. Modak  Yogesh Hospital  1158, Sadashiv Peth, Limaye wadi, Pune ,-411030
Pune
MAHARASHTRA 
020-24478740

 
 
Details of Ethics Committee  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Kotbagi Hospital Independant Ethical Committee for Dr. Anmol Maria  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Gurpreet Dhingra  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Hemal Mehta  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Indraneel Basu  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. J.B. Panase  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Madan S. Hardikar  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Malhar H. Dave  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. manoj Rohra  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Milind D. Modak  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. N. J. Karne  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. Rajendra J. Khaire  Approved 
Kotbagi Hospital Independant Ethical Committee for Dr. S. K. Singh  Approved 
SIOR's Independent Ethics committee For Dr. Parag Sancheti  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Knee Osteoarthritis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexketoprofen Trometamol Gel for topical application  Local application; TID for 14 days 
Comparator Agent  Diclofenac Gel for topical application.  Local application; TID For 14 days 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1) Male or female patients between 40- 65 years of age. 2) Patients diagnosed to have knee osteoarthritis. 3) Willing to give written informed consent and willing to comply with the trial protocol. 4) Patients not on any anti-inflammatory or other therapy known to affect the study outcome.  
 
ExclusionCriteria 
Details  1) Patients with known hypersensitivity to the study medications and/or history of any drug allergy or intolerance to NSAIDs. 2) Patients with the history of or evidence of any cardiac, renal, hepatic, neurologic or any other major medical or psychiatric illness. 3) Any contraindication to use of NSAID. 4) Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception. 5) Any condition that, in the opinion of the investigator, does not justify the patients's inclusion in the study. 6) Drug addiction or alcoholism 7) Current participation or participation within the previous three months in other clinical trials. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders.  0, 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in average VAS score. Improvement in WOMAC scores for pain, stiffness and physical function. Improvement in patient's and physician's global assessment of arthritis.  0, 14 days 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  20/05/2009 
Estimated Duration of Trial   Years=""
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary   This is a multicentric, randomized, comparative clinical trial being conducted to evaluate efficacy and safety of topical Dexketoprofen trometamol gel in treatment of knee osteoarthritis. Reference product will be Diclofenac gel. Total 200 patients (100 in each group) will be enrolled in this study. Study population comprise of subjects with age between 40 - 65 years; diagnosed to have knee osteoarthritis; willing to give written informed consent and willing to comply with trial protocol; and not on any anti-inflammatory or other therapy known to affect the study outcome. Patients will apply the medication locally thrice daily for 2 weeks. Rescue medication: Paracetamol 650 mg tablet every 6 hours, if required. Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders. Secondary efficacy measures are improvement in average VAS scores; improvement in WOMAC scores for pain, stiffness and physical function; and improvement in patient's and physician's global assessment of arthritis. Adverse events (if any) will be recorded. Patients will be evaluated at baseline and after 14 days therapy. 
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