| 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
|
|
|
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). |