| CTRI Number |
CTRI/2011/07/001922 [Registered on: 27/07/2011] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To confirm efficacy of Kallikrein in improvement of neurological scores in patients of acute ischemic stroke. |
|
Scientific Title of Study
|
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Kallikrein versus placebo alongwith standard supportive care in subjects of mild to moderate ischecmic stroke. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV/Kallikrein/2009 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uma Sundar |
| Designation |
Professor |
| Affiliation |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Sion Mumbai |
| Address |
Department of Neurology Services Internal Medicaine
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
umasundar2@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uma Sundar |
| Designation |
Professor |
| Affiliation |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Sion Mumbai |
| Address |
Department of Neurology Services Internal Medicaine
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
umasundar2@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naju Turakhia |
| Designation |
General Manager- Clinical Research |
| Affiliation |
Bharat Serums and Vaccines Ltd |
| Address |
Bharat Serums and Vaccines Ltd
1st Floor Building No1 Business Development Centre
Near Tatwagyan Vidyapeeth Ghodbunder Road
Thane (West)
Thane
MAHARASHTRA
400610
India |
| Phone |
02261383409 |
| Fax |
02261383400 |
| Email |
Naju.Turakhia@bharatserums.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Limited |
|
|
Primary Sponsor
|
| Name |
Bharat Serums and Vaccines Ltd |
| Address |
1st Floor, Building No.1, Business Development Centre,
Near Tatwagyan Vidyapeeth Ghodbunder Road,
Thane (West)- 400610
Maharashtra
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asha Shah |
B J Medical College and Civil Hospital |
Department of Medicine,
B J Medical College and Civil Hospital,Asarwa, Ahmedabad – 380 016
Ahmadabad
GUJARAT |
25502752
navneetasha@yahoo.com |
| Dr Sangeeta Ravat |
KEM Hospital and Seth G.S Medical College |
Department Of Neurology,KEM Hospital and Seth G.S Medical College, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA |
24107545
ravatsh@yahoo.com |
| Dr Anita Basavaraj |
B.J.Medical College & Sassoon General Hospital |
Department of Medicine B.J.Medical College & Sassoon General Hospital, Pune 411 001.
Pune
MAHARASHTRA |
26128000
anita.basavaraj@rediffmail.com |
| Dr MM Mehniratta |
GB Pant Hospital |
Professor of Department of Neurology, GB Pant Hospital, New Delhi- 2
New Delhi
DELHI |
011-23234350
mmehndi@hotmail.com |
| Dr Amar Pazare |
KEM Hospital and Seth G.S Medical College |
Professor and head of Department Of Medicine,KEM Hospital and Seth G.S Medical College, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA |
022-24126766
arpazare@rediffmail.com |
| Dr Anand Alurkar |
KEM Hospital Research Center |
Department Of Neurology,
KEM Hospital Research Center, Sardar Moodliar Road,Rasta Peth Pune- 4110011
Pune
MAHARASHTRA |
25538904
anand_alurkar@yahoo.co.in |
| Dr Nivedita Moulick |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital |
Professor and Head of Department of Medicine, Sion, Mumbai 400022
Mumbai
MAHARASHTRA |
24076381
ndmoulick@rediffmail.com |
| Dr Uma Sunder |
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital |
Professor,Department of Neurology Services,Internal Medicaine,
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital,Sion, Mumbai
Mumbai
MAHARASHTRA |
24076381
umasundar2@rediffmail.com |
| Dr Neelima Chafekar |
N.D.M.V.P. Samaj Medical College |
Department of Medicine,
N.D.M.V.P.Samaj Medical College,Vasantdada Nagar, Adgaon, Nasik – 422 003
Nashik
MAHARASHTRA |
2303111
neelimachafekar@yahoo.com |
| Dr Santosh Kumar |
Sagar Hospital |
Department of Neurosciences,
Jayanagar, Bangalore 560047
Bangalore
KARNATAKA |
80-42888888
drsantoshdv@gmail.com |
| Dr ST Malhan |
Seth V S Hospital |
Professor of medicine, Ahmedabad - 6
Ahmadabad
GUJARAT |
9328277120
stmalhan@yahoo.co.in |
| Dr Rahul Chakor |
T N Medical College & B Y L Nair Hospital |
Department of Neurology, T N Medical College & B Y L Nair Hospital
Mumbai- 00008
Mumbai
MAHARASHTRA |
23027509
drchakorrt@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee- KEM Hospital Research Centre,Pune |
Approved |
| Ethics Committee- KEM and seth G S Medical College, Mumbai |
Approved |
| Ethics Committee- LTMMC & LTMGH, Sion Mumbai |
Approved |
| Ethics Committee- NDMVP Samaj Medical College, Nashik |
Approved |
| Ethics Committee- Sassoon General Hospital |
Approved |
| Ethics Committee- Civil Hospital, Ahmedabad |
Approved |
| Ethics Committee- KEM and seth G S Medical College, Mumbai |
Approved |
| Ethics Committee- Maulana Azad Medical College and associated hospitals |
Approved |
| Ethics Committee- Maulana Azad Medical College and associated hospitals |
Approved |
| Ethics Committee- T N Medical College & BYL Nair Hospital |
Approved |
| Ethics Committee-VS General hospital |
Approved |
| Institutional Ethics Committee-Sagar Hospital |
Approved |
| Staff and research society-LTMMC & LTMGH, Sion Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Mild to Moderate Acute ischemic stroke, (1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kallikrein plus standard supportive care |
0.15PNA (para nitroaniline)OD X 10 Days IV |
| Comparator Agent |
Placebo |
OD X 10 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild to moderate cerebral ischemic strokes presenting within
48 hours after onset of symptoms. (NIHSS score: 4-10, mild;
11-20, moderate)
2. Male or female, aged 18 to 70 years (both inclusive)
3. No hemorrhage as proved by cerebral CT scan |
|
| ExclusionCriteria |
| Details |
1. Mean arterial blood pressure > 180/110
2. NIHSS score: >21
3. Age <18 or >70 years
4. History of dementia or neurodegenerative disease
5. Severe comorbid condition such as cancer that would limit
survival during 3 month follow-up period
6. Women of childbearing potential
7. Peptic ulcer disease, Active bleeding diathesis, Lower GI bleed
8. Hematuria
9. Prolonged PT or PTT, Thrombocytopenia or neutropenia
10. Elevated LFT / RFT
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration |
Day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in disability as measured by combined Barthel Index & modified Rankin's scale. |
Day 5, day 11, day 30, day 60 and day 90 from day 1 of IP administration |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/05/2011 |
| 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
|
Years="1"
Months="6"
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
|
The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Kallikrein as adjuvant therapy in treatment of mild to moderate ischemic strokes at a dose of 0.15 PNA o.d for 10 days. This study will be conducted in 8-10 centers in India. The primary efficacy variables will be Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration and 90 Day Mortality. The secondary efficacy variables will be reduction in disability as measured by scores. |