| CTRI Number |
CTRI/2010/091/000437 [Registered on: 21/07/2010] |
| Last Modified On: |
19/04/2016 |
| 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)
|
Etodolac injection in post operative orthopedic pain.
|
Scientific Title of Study
Modification(s)
|
Comparative evaluation of efficacy and safety of etodolac injection and diclofenac sodium injection in patients with post operative orthopedic pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/ETDI/PIII-09 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
President, Medical Affairs & Clinical Research 142-AB, Kandivli Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-28686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitin Chandurkar |
| Designation |
Deputy General Manager |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Ipca Laboratories Ltd.
Plot no. 102, Kandivli Industrial Estate, Kandivli(W)
Mumbai
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-61113165 |
| Fax |
022-61113150 |
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Limited, 142-AB, Kandivli Industrial Estate, Kandivli (West) Mumbai: 400067 |
|
Primary Sponsor
Modification(s)
|
| Name |
Ipca Laboratories Limited |
| Address |
Ipca Laboratories Ltd, 142-AB, Kandivli Industrial Estate Kandivli (W), Mumbai-400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M K Ravindran |
Calicut Medical College |
Calicut Medical College, Calicut (Kerala)-673008
Thiruvananthapuram
KERALA |
09447023525
raveendranmk@gmail.com |
| Dr Ashish Sirsikar |
Department of Orthopedics GRMC , Gwalior |
Gajara Raja Medical College , Gwalior, madhaya predesh
Gwalior
MADHYA PRADESH |
9229529409
ashish_sirsikar@rediffmail.com |
| Dr Amit Swamy |
Dr DY Patil Medical College |
Sant Tukaram Nagar, Pimpri,Pune - 411018
Pune
MAHARASHTRA |
9823175493
amit.swamy@gmail.com |
| Dr Sachin Avasthi |
GSVM Medical College |
GSVM Medical College,
Kanpur-(U.P.)- 208002
Lucknow
UTTAR PRADESH |
09235563688
sachinavasthi4778@yahoo.com |
| Dr Ashish Kumar |
King George Medical University |
King George Medical University Lucknow U.P. 226003
Lucknow
UTTAR PRADESH |
9415020202
drashish_kumar20202@yahoo.com |
| Dr Anil Gupta |
Mahatma Gandhi Medical College & Hospital |
Mahatma Gandhi Hospital, Sitapura, Jaipur,
Rajasthan- 302022
Jaipur
RAJASTHAN |
9887501594
drguptaanil2004@yahoo.co.in |
| Dr G Marulasiddappa |
Mysore Medical College and Research Institute, K. R. Hospital, Mysore |
Mysore Medical College and Research Institute, K. R. Hospital,Mysore - 570001, Karnataka
Mysore
KARNATAKA |
09844319497
gmsortho@gmail.com |
| Dr Yatin Desai |
Sheth Vadilal Sarabhai General Hospital & |
Sheth Vadilal Sarabhai General Hospital, Ellis Bridge Ahemedabad - 380006
Ahmadabad
GUJARAT |
26577621
26577647
dr.yatin@gmail.com |
| Dr Deepak Kumar Jha |
Vivekananda Institute of Medical Sciences |
Vivekananda Institute of Medical Science, 99 Sarat Bose Road, Kolkata- 700026
Kolkata
WEST BENGAL |
09830038210
jhabhaswati@gmail.com |
| Dr Hiranya Kumar S |
Vydehi Institute of Medical Sciences and Research Centre |
# 82, Nallurahalli, Near BMTC 18th Depot,,Whitefield-560 066
Bangalore
KARNATAKA |
080-28413381
08028412956
drhiranyak@gmail.com |
| Dr Imthiaz Ahammed K A |
Yenepoya Medical College Hospital |
Yenepoya Medical College, Deralakatte, Manglore-575018
Dakshina Kannada
KARNATAKA |
9845082578
drimth@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Commitee, Mysore Medical College and Research Institute,Mysore |
Approved |
| Institutional Ethics Committee of Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee Padmashree Dr. D. Y. Patil Medical College |
Approved |
| Institutional Ethics Committee Vydehi Institute of Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee, Government Medical College,Calicut |
Approved |
| Institutional Ethics Committee,King George Medical University, Lucknow |
Approved |
| Institutional Ethics Committee,Ramakrishna Mission Seva Prtisthan,Vivekanand Institute of Medical Sciences, Kolkata |
Approved |
| Mahatma Gandhi Medical College & Hospital, Jaipur |
Approved |
| Office of the Dean GR Medical College, Gwalior |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Post Operative Orthopedic pain , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac |
75mg Injection (IM) |
| Intervention |
Etodolac |
400mg injection (IM) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged 18 to 65 years
2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition
3. Patients who are undergoing any of the following elective orthopedic surgeries such asknee arthroscopy, repair of femoral neck fracture, repair of trochanteric fracture, repair of ankle fracture (bimalleolar type), repair of femoral or tibial fracture, fixation for foot injuries, fixation for pelvic fractures and repair of patella fracture.
4.Patients with the post operative orthopedic pain of at least 5cm on the 10cm pain intensity Visual Analogue Scale and at least a score of 2 on 4 point verbal rating scale
5. Patients fulfilling the American Society of Anesthesiology (ASA) I or II or III criteria for post operative orthopedic pain
6. The subject must understand and be able, willing and likely to fully comply with study procedures and ready to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients having complication during or after surgical procedure
2. Patients with abnormal renal and liver function
3. Patients with significant medical illness
4. Patient having any concomitant medication, which may interact with action of study drugs.
5. Patients with known history of hypersensitivity to NSAIDS or diclofenac or any other ingredient of the study medication or other similar drugs of same chemical class
7. Pregnant or lactating women
8. Women of childbearing potential not practicing contraception
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean fall in pain intensity |
At 15 min, 30 min, 1 hr and then 2, 4, 6, 8, 12, 16, 20 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total doses of rescue medication consumed |
In the entire study duration |
| Safety and toleability of study medication |
throughout the duration of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
26/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized, assessor blind, comparative, multicentric study. The investigator will obtain written informed consent from the patient before screening. Additional 100 patients undergoing elective orthopedic surgeries will be enrolled as per the inclusion and exclusion criteria. After surgery, all inclusion/exclusion criteria will be evaluated. Patients who satisfy the inclusion and exclusion criteria will be randomized in to two treatment arms.Total study duration will be 24 hours. After one week of study completion, the telephonic follow up will be done by the investigator to evaluate the safety of study drug. In this follow up, investigator will ask the patients about any AE/SAE experienced by them. |