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CTRI Number  CTRI/2016/10/007400 [Registered on: 24/10/2016] Trial Registered Prospectively
Last Modified On: 05/04/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A observational study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administration  
Scientific Title of Study   International, multicenter, randomized, open-label comparative study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administration 5000 anti-Xa IU/0.2 ml and Fragmin®, solution for intravenous and subcutaneous administration 500 anti-Xa IU/0.2 ml in patients undergoing surgery for endprosthesis replacement of large joints of the lower extremities, with a high risk of thrombotic or thromboembolic complications in the postoperative period.‖ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NEX/JSC/DAL-III/2016, 1.4, 01/07/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Bhatt 
Designation  President and CEO 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax  09167243914  
Email  hbo@nexuscro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Bhatt 
Designation  President and CEO 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax  09167243914  
Email  hbo@nexuscro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mangesh khadakban 
Designation  manager 
Affiliation  Nexus Clinical Research (India) Ltd. 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence, Shiravane Road Service Industry Sector 1 Mumbai Pune Highway Nerul, Navi Mumbai India

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9167243914  
Fax  09167243914  
Email  mangesh.khadakban@nexuscro.com  
 
Source of Monetary or Material Support  
JSC Pharmasyntez, Russia Krasnoarmeyskaya 23, office 3, 664007, Irkutsk, Russia. Russia, 664007, ul. Krasnogvardeyskaya 23,3. 
 
Primary Sponsor  
Name  JSC Pharmasyntez 
Address  JSC Pharmasyntez, Russia Krasnoarmeyskaya 23, office 3, 664007, Irkutsk, Russia. Russia, 664007, ul. Krasnogvardeyskaya 23,3 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NEXUS CLINICAL RESEARCH INDIA LTD  32 A, Nexus Center For Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai – 400 706. 
 
Countries of Recruitment     India
Russian Federation  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bipin Mohapatra  Hi Tech Medical College and Hospital   Hi Tech Medical College and Hospital Department of Orthopedics Second floor Room No. 06 Division Orthopedics Pandara Rasulgarh Bhubaneshwar Odisha 751025 Cuttack ORISSA Cuttack ORISSA
Cuttack
ORISSA 
9861252518

behera.saiprasanna82@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Cuttack Diabetes Research Foundation  Submittted/Under Review 
Hi Tech Medical College and Hospital Institutional Ethics Committee   Approved 
Institute of Medical Science and SUM Hospital Ethics Committe  Submittted/Under Review 
Kalinga Institute of Medical Science Institutional Ethics Committe  Submittted/Under Review 
NRS Medical college and Hospital Institutional Ethics Committe  Submittted/Under Review 
Rajiv Gandhi Institute of Medical Sciences (RIMS) IEC  Submittted/Under Review 
Sparsh Hospital Institutional ethics committe  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  For the Treatment of thrombotic or thromboembolic complications in the postoperative period.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dalteparin Sodium 5000 anti-Xa IU  Dosage form Solution for intravenous and subcutaneous administration 
Comparator Agent  Fragmin 5000 (anti-Xa) IU  Dosage Form Solution for intravenous and subcutaneous administration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Informed consent signed by the patient before beginning any procedures.
2. Patients aged from 18 to 70 years old inclusive of both genders.
3. Planned surgical intervention for knee or hip joint endoprothesis replacement. Operational intervention with spinal or epidural anesthesia without epidural or peridural catheter.
4. Negative pregnancy test result for female patients.
5. Consent of fertile female and male patients to use barrier metho 
 
ExclusionCriteria 
Details  1 Patients hypersensitive to Dalteparin Sodium, heparin sodium or its compounds, including other low-molecular heparins.
2 Women weighing under 45 kg and men under 57 kg.
3 Patients having diseases with high risk of bleeding (hemorrhagic stroke, cerebral aneurysm or aortic dissection, uncontrolled bleeding) in history.
4 History of verified or suspected Dalteparin- or heparin-induced thrombocytopenia
5 Acute coronary syndrome, ACF. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Deep vein thrombosis of lower extremities, including proximal, distal, symptomatic, and asymptomatic   ones within 14 days after surgery; 
 
Secondary Outcome  
Outcome  TimePoints 
Pulmonary embolism (PE)   within 14 days after surgery 
Cases of major bleedings  within 14 days after surgery 
Cases of all clinically significant bleedings  within 14 days after surgery 
Cases of necessities for blood transfusion  within 14 days after surgery 
Cases of clinically significant anemia  within 14 days after surgery 
Cases of bleedings causing a necessity of recurrent surgical intervention  Cases of clinically significant anemia 
Incidence of other adverse events, to some extent related to the administered test drug or reference drug, including the ones evaluated on the results of laboratory  During the study 
 
Target Sample Size   Total Sample Size="190"
Sample Size from India="160" 
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   N/A 
Date of First Enrollment (India)   01/11/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/10/2016 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="16" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Open-label, multicenter, randomized, comparative study in parallel groups
Group I will be administered Dalteparin Sodium, solution for intravenous and subcutaneous administration 5 000 anti-Xa IU/0.2 ml ("Camus Pharma Pvt. Ltd.", India) subcutaneously in a dose of 5000 IU in the evening before the day of surgery, then 5000 IU every evening after the surgery. Therapy will last for 12-14 days (including the day of surgery) depending on regular procedure of the clinical site.
Group II will be administered Fragmin®, solution for intravenous and subcutaneous administration 5000 anti-Xa IU/0.2 ml ("Pfizer MFG. Belgium N.V.", Belgium) subcutaneously in a dose of 5000 IU in the evening before the surgery, then 5000 IU every evening after the surgery. Therapy will last for 12-14 days (including the day of surgery), depending on regular procedure of the clinical site.
Intermediate visit to evaluate tolerability and safety of study therapy will be performed after 5 days ± 2 days.
Evaluation of therapy efficacy and safety will be performed after 14 ± 2 days of therapy, then depending on Investigator‘s conclusion, a patient will be discharged from the hospital and will be administered oral forms of anticoagulants as per the standard practice of clinical site (oral forms of anticoagulants approved in the RF: warfarin, dabigatran, rivaroxaban). If patient‘s condition is not acceptable for outpatient treatment, his hospitalization may be prolonged.
Test drug and reference drug are administered subcutaneously, injection sites should be changed daily (contralateral injections every next day of treatment).
 
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