FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2009/091/000388 [Registered on: 22/06/2009]
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 of efficacy & safety of dexketoprofen injection compared to diclofenac injection in post-operative pain 
Scientific Title of Study   A clinical trial to assess the efficacy and safety of Injection Dexketoprofen Trometamol in the treatment of Post-operative Pain  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
Study Code: Emc/PP/DEXKT/12/2008  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrihari Dhore Patil 
Designation   
Affiliation   
Address  Shree Hospital
Opp DASS Showroom, Siddharth Mansion
Pune
MAHARASHTRA
411014
India 
Phone  02026681127  
Fax    
Email  sdhorepatil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR BHAGWAT K GUNALE 
Designation   
Affiliation  EMCURE PHARMACEUTICALS 
Address  Marketing Division, Emcure Pharmaceuticals Limited
Rajiv Gandhi IT Park, Phase 1 MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India 
Phone  02039821000  
Fax  02039821019  
Email  Bhagwat.Gunale@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  DR BHAGWAT K GUNALE 
Designation   
Affiliation   
Address  Marketing Division, Emcure Pharmaceuticals Limited
Rajiv Gandhi IT Park, Phase 1 MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India 
Phone  02039821000 - 2544  
Fax  02039821019  
Email  Bhagwat.Gunale@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 = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemal Bhagat  CRITICARE HOSPITAL  Consulting General and Laparoscopic surgeon,,Criticare Hospital, JVPD Scheme,Gulmohar Park, Andheri (W),-400049
Mumbai
MAHARASHTRA 
02226101883

hemalbhagat@hotmail.com 
Dr Kishore Bhagtani  Dr R N Cooper Municipal General Hospital  Dr Dr R N Cooper Municipal General Hospital,Vile Parle (West)-400056
Mumbai
MAHARASHTRA 
+91-22-26207254

kishorebhagtani@yahoo.com 
Dr Subhas S Erram  ERRAM HOSPITAL  Shivanjali, near Krishna Bridge,Station Road, Karad -415110

 
02164 - 222440

subhasherram@hotmail.com 
Dr P T Jamdade  Government Medical College, Nanded.  ,-
Nanded
MAHARASHTRA 


 
Dr. Vijay Kamat   Karnataka Institute of Medical Sciences, Hubli  Asst Prof, Dept of Surgery,Vidya Nagar-580020

 


kamatvv@gmail.com 
Dr Jeevan V Shinde  Noble Hospital & Research Centre  Dhanaji Nagar, Premdan Chowk,Manmad Road, Savedi-414001

 


jeevanshinde@yahoo.com 
Dr. S. S. Kolte  Sahyadri Speciality Hospital  30 C, Erandawane, Karve Road,-411004
Pune
MAHARASHTRA 


 
Dr Ashwin Porwal  Sharada Clinic  408/1 Ekbote Colony,Ghorpade Peth, Shankarseth Road-411042
Pune
MAHARASHTRA 
02026438949

drashwinporwal@rediffmail.com 
Dr Pushparaj S Karmarkar  SHASHWAT HOSPITAL  22, Happy colony,Kothrud-411038
Pune
MAHARASHTRA 
02025452052

shashwathospital@gmail.com 
Dr Shrihari Dhore Patil  SHREE HOSPITAL  Opposite DASS Showroom,Siddarth Mansion, Nagar Road-411014
Pune
MAHARASHTRA 
020 26681127

shrihari@vsnl.com 
Dr. Ravindra Irpatgire   Shri Venkatesh Hospital  Barshi Road,-413512
Latur
MAHARASHTRA 


 
 
Details of Ethics Committee  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethical Committee, Kotbagi Hospital for Dr. Ravindra Irpatgire  Approved 
Ethics Committee Dr R N Cooper Municipal General Hospital  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
ETHICS COMMITTEE KOTBAGI HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE, SHRI SHANKARRAO CHAVHAN GOVERNMENT MEDICAL COLLEGE, NANDED  Approved 
Sahyadri Speciality Hospitals Ethics Committee for Dr. S. S. Kolte   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain management in hernia repair patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXKETOPROFEN INJECTION  Single injection of 50 mg to be given deep intramuscularly 
Comparator Agent  DICLOFENAC INJECTION  Single injection of 50 mg deep intramuscularly 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Male or female patients between 18- 65 years of age. 2. Patients undergoing surgery for (Inguinal/Incisional/Umbilical/Congenital/Other) hernia repair 3. Willing to give written informed consent and willing to comply with the trial protocol. 4. Patients with normal baseline laboratory parameters.  
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to the study medications and /or history of any drug allergy or intolerance to NSAIDs or any anesthetic medication. 2. Complication during or after surgical procedure. 3. Patients on any anti-inflammatory or other therapy known to affect the study outcome. 4. Patients with active or suspected gastrointestinal ulcer / history of gastrointestinal ulcer / chronic dyspepsia or gastrointestinal bleeding. 5. Patients with Crohn?s disease or ulcerative colitis 6. Patients with history of bronchial asthma 7. Patients with severe heart failure / moderate to severe renal dysfunction (Creatinine clearance < 50 ml/min) or severely impaired hepatic function (Child- Pugh score 10- 15) 8. Patients with hemorrhagic diathesis and other coagulation disorders 9. Any contraindication to use of NSAID. 10. Drug addiction or alcoholism. 11. Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception. 12. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study. 13. Current participation or participation within the previous three months in other clinical trials.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Injection dexketoprofen trometamol in the treatment of postoperative pain.  Baseline, 1, 2, 4, 6 and 8 hours after the injection. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Injection dexketoprofen trometamol in the treatment of postoperative pain.   Baseline, 1, 2, 4, 6 and 8 hours after the injection. 
 
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" 
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)  23/06/2009 
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    
Brief Summary   Study Title: A clinical trial to assess efficacy and safety of Injection Dexketoprofen trometamol in treatment of postoperative pain. Study Code: Emc/PP/DEXKT/12/2008 Indication Studied: Postoperative pain. Study Design: Multicentric, randomized, comparative clinical trial Study Duration: Approximately 1 day. Drugs under evaluation: Test: Injection Dexketoprofen trometamol Control: Injection Diclofenac sodium Dosage and regimen: Injection Dexketoprofen trometamol 50 mg postoperatively immediately when patient complains of moderate to severe pain. Injection Diclofenac sodium 50 mg postoperatively immediately when patient complains of moderate to severe pain. Formulation: Test: Injection Dexketoprofen trometamol 25 mg/ml ampoule. Control: Injection Diclofenac sodium 25 mg/ml, 3 ml ampoule. Inclusion Criteria: 1. Male or female patients between 18 - 65 years of age. 2. Patients undergoing hernia repair surgery. 3. Willing to give written informed consent and willing to comply with the trial protocol. 4. Patients with normal laboratory values. Exclusion Criteria: 1. Patients with known hypersensitivity to the study medications and /or history of any drug allergy or intolerance to NSAIDs. 2. Complication during or after surgical procedure. 3. Patients on any anti-inflammatory or other therapy known to affect the study outcome. 4. Patients with active or suspected gastrointestinal ulcer / history of gastrointestinal ulcer / chronic dyspepsia or gastrointestinal bleeding. 5. Patients with Crohn?s disease or ulcerative colitis 6. Patients with history of bronchial asthma 7. Patients with severe heart failure / moderate to severe renal dysfunction (Creatinine clearance < 50 ml/min.) or severely impaired hepatic function (Child- Pugh score 10- 15) 8. Patients with hemorrhagic diathesis and other coagulation disorders 9. Any contraindication to use of NSAID. 10. Drug addiction or alcoholism. 11. Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception. 12. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study. 13. Current participation or participation within the previous three months in other clinical trials. Expected Total Enrollment: 200 (100 in each group) Efficacy measures: Primary efficacy measures: Proportion of patients having more than 50 % pain relief within 8 hours. 2.4.2: Secondary efficacy measures: Time of onset of significant decrease in VAS scores. Comparison of sum analogue of pain intensity difference (SAPID). Comparison of pain intensity difference (PID) at 8th hour of injection. Patients assessment of onset of analgesia, duration of analgesia, and change in VAS pain scores in subsequent visits and adverse drug reactions.  
Close