| CTRI Number |
CTRI/2009/091/000274 [Registered on: 20/05/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| 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 |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Emc/KO/DEXKT/01/2008 |
Protocol Number |
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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 |
|
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Source of Monetary or Material Support
|
| Emcure Pharmaceuticals Limited, Pune. |
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Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Limited, Pune. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| 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
|
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| 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
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Knee Osteoarthritis, |
|
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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 |
|
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Inclusion Criteria
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| 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.
|
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| 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. |
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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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 |
|
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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 |
|
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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. |