FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2009/091/000720 [Registered on: 10/09/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to evaluate the efficacy and tolerability of FDC of S(+)-Etodolac and Paracetamol Tablet in acute musculoskeletal pain  
Scientific Title of Study   Clinical study to evaluate the efficacy and tolerability of FDC of S(+)-Etodolac and Paracetamol Tablet in acute musculoskeletal pain  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Study Code- EPL/S(+)EP/2009/01  Other 
 
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
Krishna Chembers, Opp - Laxmi Narayan Theatre, Near Swargate
Pune
MAHARASHTRA
411037
India 
Phone  020-24265148  
Fax    
Email  njkarne@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Onkar Swami 
Designation   
Affiliation  Manager - Medical Services 
Address  Emcure Pharmaceuticals Ltd
Survey No 255/2 Phase 1, Rajiv Gandhi IT Park, MIDC Hinjwadi
Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821018  
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Public Query  
Name  Dr. Onkar Swami 
Designation   
Affiliation   
Address  Emcure Pharmaceuticals Ltd
Survey No 255/2 Phase 1, Rajiv Gandhi IT Park, MIDC Hinjwadi
Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821018  
Email  Onkar.Swami@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd, Pune 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd, Pune 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. C. M. Azhar Almas  Chowdry Orthopaedic Centre  No. 182, Nandidurga Road Crescent,Benson Town-560048
Bangalore
KARNATAKA 		 080-3533476

azharalmas@yahoo.com 
Dr. Gurpreet Dhingra  Dr. Gurpreet Dhingra  4 Asiya manzil, Kishore Kumar Ganguly Marg,Juhu Tara Road, Santacruz (w)-400049
Mumbai
MAHARASHTRA 		 022-26606623

grprt.dhingra@gmail.com 
Dr. Madan S. Hardikar  Hardikar Hospital  Hardikar Hospital,Shivaji Nagar-411005
Pune
MAHARASHTRA 		 020-25535326

madanhardikar@vsnl.net 
Dr. M. Kirankumar  Jaynagar General Hospital  Jaynagar General Hospital,4th T Block Jaynagar -560041
Bangalore
KARNATAKA 		 09448078396

 
Dr. J. B. Panse  Panse Clinic  Panse Clinic 10/73,Agarkar Nagar-411001
Pune
MAHARASHTRA 		 020-26126524

jbpanse@bsnl.in 
Dr. N.J. Karne  Pune Institute of Accident and Orthopedics  Krishna Chambers, Opp. Laxmi Narayan Theatre,,Near Swargate,-411 037
Pune
MAHARASHTRA 		 09822036724

 
Dr. Indraneel Basu  Ram Krishna Mission Hospital  Ram Krishna Mission Hospital,LUXA-221002
Varanasi
UTTAR PRADESH 		 0542-3251542

dribasumd@yahoo.co.in 
Dr. Alok Datta  RITTIK (Clinic & Laboratory)  155 A, A.J.C. Bose Road,,-700014
Kolkata
WEST BENGAL 

 
Dr. Rajendra J. Khaire  Shri Guruji Rugnalaya  Umiya Appartment II Floor,Canada Corner-422005
Nashik
MAHARASHTRA 		 0253-2318601

drrajendrakhaire@yahoo.co.in 
Dr. Milind Modak  Yogesh Hospital  1188, Limaye wadi,Sadashiv Peth-411030
Pune
MAHARASHTRA 		 020-24478740

drmilindmodak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Independant Ethics Committee, Danashree Hospital, for Dr. Alok Datta  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. C. M. Azhar Almas  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. Gurpreet Dhingra  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. Indraneel Basu  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. J. B. Panse  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. M. Kirankumar  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. M. S. Hardikar  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. Milind Modak  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. N. J. Karne  Approved 
Independant Ethics Committee, Danashree Hospital, for Dr. Rajendra J. Khaire  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute musculoskeletal pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FDC of Diclofenac sodium (50 mg) and Paracetamol (500 mg) tablet  1 tablet thrice daily 
Intervention  FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet  1 tablet twice daily 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
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.  
 
ExclusionCriteria 
Details  1) Patients previously sensitive to S-Etodolac, 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   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Responder rate  Baseline, after 3 days of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
1) Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS). 2)Sum of pain intensity differences (SPID) on categorical verbal scale (VS). 3) Total pain relief score (TOTPAR) on VS. 4)Patient?s global assessment of the efficacy of the drug 5)Physician?s global assessment of the efficacy of the drug  Baseline and after 3 days of therapy 
1) Patient's global assessment about the tolerability of the drug 2) Any adverese events will be noted.  After 3 days of therapy 
 
Target Sample Size   Total Sample Size="100"
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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/09/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years=""
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This multicentric randomized, comparative clinical trial is proposed to assess the efficacy and tolerability of FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet in acute musculoskeletal pain. The secondory objective of the study is to compare the efficacy and tolerability of FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet with FDC of Diclofenac (50 mg) and Paracetamol (500 mg) tablet in acute musculoskeletal pain. Patients visiting the OPDs for acute musculoskeletal pain will be enrolled in this study. After satisfing exclusion and inclusion criteria, 100 patients with acute musculoskeletal pain will be enrolled in the study. Each enrolled patient will receive treatment with either FDC of S-Etodolac (300 mg) and Paracetamol (500 mg) tablet twice daily OR with FDC of Diclofenac (50 mg) and Paracetamol (500 mg) tablet thrice daily. Each treatment will be administered for three consecutive days. Patients will be evaluated on baseline and after three days of therapy for pain intensity and pain relief score. Safety variables will be Patient's global assessment about the tolerability of the drug. Any Adverse event repored will be recorded. 
Close