| CTRI Number |
CTRI/2009/091/000932 [Registered on: 17/11/2009] |
| 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 |
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Public Title of Study
|
Efficacy and Safety of Dexketoprofen extended release tablet in the Treatment of Osteoarthritis |
|
Scientific Title of Study
|
A Multicentric, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Dexketoprofen ER Tablet in the Treatment of Osteoarthritis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Emc/Dxkt-ER/001 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. N.J. Karne, M.S. (Ortho) |
| Designation |
|
| Affiliation |
|
| Address |
Pune Institute of Accident and Orthopedics,
Krishna Chambers, Opp. Laxmi Narayan Theatre,
Pune
MAHARASHTRA
411037
India |
| Phone |
02024265148 |
| Fax |
|
| Email |
njkarne@hotmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Onkar Swami, MBBS; MD. |
| Designation |
|
| Affiliation |
Manager - Medical Services |
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC,
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821000 |
| Fax |
02039821019 |
| Email |
Onkar.Swami@emcure.co.in |
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Details of Contact Person
Public Query
|
| Name |
Dr. Onkar Swami, MBBS; MD. |
| Designation |
|
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC,
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821000 |
| Fax |
02039821019 |
| Email |
Onkar.Swami@emcure.co.in |
|
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Source of Monetary or Material Support
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| Emcure Pharmaceuticals Ltd, Pune |
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Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Ltd, 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 = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Malhar Dave |
Abhishek Orthopedic Hospital |
Shivalik Complex,Subhanpura main road-390007
|
abhishekhospital@yahoo.com |
| Dr. S. K. Singh |
Apex Hospital |
DLW HYDIL Road,-221004
Varanasi
UTTAR PRADESH |
05422318716
05422317414
md@apexhospitalvaranasi.com |
| Dr. C. M. Azhar Almas |
Chowdry Orthopedic Centre |
No 182, Nandidurga Road Crescent,Benson Town-560046
Bangalore
KARNATAKA |
|
| Dr. M.S. Hardikar |
Hardikar Hospital |
Shivajinagar,-411005
Pune
MAHARASHTRA |
|
| Dr. N. J. Karne |
Pune Institute of Accident and Orthopedics |
Krishna Chambers, Opp. Laxmi Narayan Theatre, ,Near Swargate,-411 037
Pune
MAHARASHTRA |
njkarne@hotmail.com |
| Dr. Alok Datta |
RITTIK (Clinic & Laboratory) |
155 A, A.J.C. Bose Road,-700014
Kolkata
WEST BENGAL |
|
| Dr. Indraneel Basu |
Sanjeevani Clinic |
Opp. Gauriya Muth, Sonarpura,-
Varanasi
UTTAR PRADESH |
|
| Dr. Subhash S. Erram |
Sharda Clinic, Erram Hospital |
Near Krishna Bridge, Station Road,,Karad -415110
|
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| Dr. Rajendra J. Khaire |
Shri Guruji Rugnalaya |
IInd Floor, Umiya Appartment,Dr. Hedgewar Chowk, Canada Corner-422005
Nashik
MAHARASHTRA |
02532318601
drrajendrakhaire@yahoo.co.in |
| Dr. Vivek S. Potdar |
Soham Hospital |
Soham Hospital,,-
Ratnagiri
MAHARASHTRA |
|
| Dr. Amit Agarwal |
VIMS Speciality Hospitals |
88, Marathahalli, Outer Ring Road,-560037
Bangalore
KARNATAKA |
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Details of Ethics Committee
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| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Alok Datta |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Amit Agarwal |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. C. M. Azhar Almas |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Indraneel Basu |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. M.S. Hardikar |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Malhar Dave |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. N. J. Karne |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Rajendra J. Khaire |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. S. K. Singh |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Subhash S. Erram |
Approved |
| Independent Ethics Committee, Dhanashree Hospital For Dr. Vivek S. Potdar |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexketoprofen Extended Release Tablets |
75 mg OD |
| Comparator Agent |
Dexketoprofen Immediate Release tablets |
25 mg TID |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
? Male or female patients between 40-75 years of age.
? Willing to give written informed consent and willing to comply with trial protocol.
? Clinically and/or radiologically diagnosed to have OA or are known OA patients
? Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
? Patients with normal laboratory values.
? Patients not on any anti-inflammatory or other therapy known to affect the study outcome.
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| ExclusionCriteria |
| Details |
? Patients with history of any drug allergy or intolerance to NSAIDs.
? Severe hypertension or uncontrolled hypertension
? Patients with H/O or evidence of renal, hepatic or neurologic diseases
? Uncontrolled diabetes
? Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.
? Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Responder rate (patients with at least 20% improvement in WOMAC total Score) |
Baseline, after 14 and 28 days of therapy. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Improvement in average VAS score
2)Improvement in average WOMAC scores for pain, stiffness and physical function
3)Improvement in patient?s and physician?s global assessment of arthritis. |
Baseline, after 14 and 28 days of therapy. |
|
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Target Sample Size
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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) |
17/11/2009 |
| 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, open lable, comparative clinical trial to compare the efficacy and safety of Dexketoprofen extended release Tablet versus Dexketoprofen immediate release tablet in the treatment of osteoarthritis. After satisfing exclusion and inclusion criteria, subjects with osteoarthritis will be randomized to two treatment groups: Dexketoprofen ER tablets and Dexketoprofen IR tablets. The efficacy and safety variables will be assessed after 14 days and 28 days of therapy. The results will be compared between two groups. Any Adverse event repored will be recorded. |