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CTRI Number  CTRI/2009/091/000114 [Registered on: 31/03/2009]
Last Modified On: 26/10/2012
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
Clinical study of the combination of Dexketoprofen and Paracetamol in acute musculoskeletal pain 
Scientific Title of Study
Modification(s)  
Clinical study to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
EPL/DXKT-P/2008/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr N J Karne 
Designation   
Affiliation   
Address  Pune Institute of Accident and Orthopedics, Krishna Chambers,
Near Swargate, Pune - Satara Road
Pune
MAHARASHTRA
411037
India 
Phone  020-24265148  
Fax    
Email  backache@vsnl.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Sudhir Surwade 
Designation   
Affiliation  Manager-Clinical Projects 
Address  Emcure Pharmaceuticals Ltd., Phase I, MIDC, Hinjwadi

Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821019  
Email  Sudhir.Surwade@emcure.co.in  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Sudhir Surwade 
Designation   
Affiliation   
Address  Emcure Pharmaceuticals Ltd., Phase I, MIDC, Hinjwadi

Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821019  
Email  Sudhir.Surwade@emcure.co.in  
 
Source of Monetary or Material Support
Modification(s)  
Emcure Pharmaceuticals Limited 
 
Primary Sponsor
Modification(s)  
Name  Emcure Pharmaceuticals Limited Pune 
Address  Survey No. 255/2, Phase I, Hinjwadi MIDC, Pune-411 057,  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Nil  NA 
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Paresh Patil  City Medical Center  City Medical Center,Shaniwar Peth-415110

 
02164225959

alaukika@dataone.in 
Dr. M. S. Hardikar  Hardikar Hospital, Pune  Hardikar Hospital,Shivaji Nagar-411005
Pune
MAHARASHTRA 
02025535326

hardikar@vsnl.com 
Dr J B Panse  Panse Clinic, Pune  Panse Clinic,10/73, Agarkar Nagar-411001
Pune
MAHARASHTRA 
02026126524

jbpanse@bsnl.in 
Dr. Sandeep Patil  Patil Orthopaedic Hospital  Patil Orthopaedic Hospital,Shaniwar Peth-415110

 
02164225776

none 
Dr. N. J. Karne  Pune Institute of Accident and Orthopedics, Pune  Pune Institute of Accident and Orthopedics,Krishna Chambers, Satara Road-411037
Pune
MAHARASHTRA 
02024265148

backache@vsnl.com 
Dr. N. S. Dhaniwala  Shri Shankarrao Chavan Government Medical College, Vajirabad, Nanded  Professor and Head, Department of Orthopedics,,Shri Shankarrao Chavan Government Medical College, Vajirabad, Nanded-431601
Nanded
MAHARASHTRA 
9422188450

 
Dr. Mahesh Patil  Suman Accident Hospital, Pune  Suman Accident Hospital,Neeta Park, Yerwada-411006
Pune
MAHARASHTRA 
02065008699

drmaheshpatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
IEC-Shri Shankarrao Chavan GMC, Nanded- For Dr. N.S. Dhaniwala  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. D. D. Kekare  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. J. B. Panse  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. M. S. Hardikar  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Mahesh Patil  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. N. J. Karne  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Paresh Patil  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Sandeep Patil  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute musculoskeletal pain,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  FDC of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg)   Dose and duration- One tablet to be taken orally, thrice daily for three consecutive days. 
Comparator Agent  FDC of Diclofenac sodium (50 mg) and Paracetamol (500 mg)   Dose and duration- One tablet to be taken orally, thrice daily for three consecutive days. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female patients between 18-65 years of age.
2. Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain
3. Patients willing to give written informed consent and willing to comply with trial protocol.
comply with trial protocol.
 
 
ExclusionCriteria 
Details  1. Patients previously sensitive to dexketoprofen, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product 2. Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema. 3. Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia. 4. Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders. 5. Patients with Crohn?s disease or ulcerative colitis. 6. Patients with a history/ presence of bronchial asthma. 7. Patients with severe heart failure 8. Patients with moderate to severe renal dysfunction 9. Patients with severely impaired hepatic function 10. Patients with hemorrhagic diathesis and other coagulation disorders 11. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception 12. Treatment with other analgesic and/or anti-inflammatory agent 13. Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug 14. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study  
 
Method of Generating Random Sequence
Modification(s)  
Computer generated randomization 
Method of Concealment
Modification(s)  
Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  
Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
The responder rate, defined as the percent of patients showing at least 50% improvement on VAS.  0,1,6,12,24,48 and 72 hours 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Total pain relief score (TOTPAR) on VS.  0,1,6,12,24,48 and 72 hours 
Patient?s global assessment of the efficacy of the drug  0,1,6,12,24,48 and 72 hours 
Physician?s global assessment of the efficacy of the drug  0,1,6,12,24,48 and 72 hours 
Sum of pain intensity differences (SPID) on categorical verbal scale (VS).   0,1,6,12,24,48 and 72 hours 
Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS)  0,1,6,12,24,48 and 72 hours 
 
Target Sample Size
Modification(s)  
Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
16/03/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  16/03/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="0"
Days="8" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
This is a comparative, randomized, multicentric, clinical trial to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain. This study is presently being conducted in 100 patients from various centers in India. Patients will be randomized to receive either Fixed Dose Combination of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg) or Fixed Dose Combination of Diclofenac sodium (50 mg) and Paracetamol (500 mg). Dose will be one tablet to be taken orally, thrice daily for three consecutive days. Major outcomes measured will be Responder rate, reduction in pain intensity on VAS, Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS), Sum of pain intensity differences (SPID) on categorical verbal scale (VS), Total pain relief score (TOTPAR) on VS, patients and physician’s global assessment and ADR. 
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