| CTRI Number |
CTRI/2011/06/001849 [Registered on: 30/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Artesunate Injection in Treatment of Plasmodium falciparum Malaria |
|
Scientific Title of Study
|
A bridging study comparing efficacy and safety of novel formulation of artesunate injection in treatment of Plasmodium falciparum malaria |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Ipca/ARIN/PIII-10, Amendment no. 1, version date: 30/09/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Ipca Laboratories Limited
142 AB, Kandivli Industrial Estate
Mumbai
MAHARASHTRA
400067
India |
| Phone |
09819768944 |
| Fax |
|
| Email |
anilpareek@ipca.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nitin Chandurkar |
| Designation |
Deputy General Manager |
| Affiliation |
|
| Address |
Ipca Laboratories Limited
48, Kandivli Industrial Estate
Mumbai
MAHARASHTRA
400067
India |
| Phone |
09324681197 |
| Fax |
|
| Email |
nitinchandurkar@ipca.co.in |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Limited |
|
|
Primary Sponsor
|
| Name |
Ipca Laboratories Limited |
| Address |
Knadivali Industrial Estate Kandivali (W), Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NB Vijay Kumar |
Andhra Medical College & King George Hospital |
King George Hospital,OPD Room No. 15, Visakhapatanam-530002
Visakhapatnam
ANDHRA PRADESH |
09246614443
drvijaykumarnb@yahoo.co.in |
| Dr SS Devvarmani |
BLDEUs Shri BM Patil Medical College |
Department of Medicine, Room No. 5, Ground floor,BLDEUs Shri BM Patil Medical College, Bijapur,-586103
Bijapur
KARNATAKA |
091-9341611512
ssdevarmani@indiatimes.com |
| Dr Himanshu Rana |
GMERS Medical College and General Hospital |
Old TB Road, Gotri, Vadodara-390021
Vadodara
GUJARAT |
9824036537
drhimanshurana@yahoo.com |
| Dr K N Bhatt |
Government Medical College & New Civil Hospital |
Department of Medicine,Room No: 12,New, Civil Hospital,Surat -395001
Surat
GUJARAT |
09825190476
knbsurat@hotmail.com |
| Dr Arvind Jain |
S. N. Medical College & Hospital |
S. N. Medical College & Hospital,
dept of Medicine, Jodhpur
Jodhpur
RAJASTHAN |
09314743757
drarvindjain@gmail.com |
| Dr J D Lakhani |
Smt BK Shah Medical College & Dhiraj Hospital |
Department of medicine,Smt BK Shah Medical College & Dhiraj Hospital, Piparia-391760
Vadodara
GUJARAT |
09974009181
jitendralakhani@doctor.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
| Institutional Ethics Commitee King George Hospital |
Approved |
| Institutional Ethics Committee, BLDEU?s Shri BM Patil Medical College, Bijapur |
Approved |
| Institutional Ethics Committee, government medical college, Surat |
Approved |
| Institutional Human Ethics Committee (Institutional Review Board) |
Approved |
| Sumandeep Vidyapeeth University Institutional Ethics Committee For Human Research |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Plasmodium falciparum malaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Artesunate injection |
Artesunate 2.4mg/kg body weight I.V. or I. M. to be administered at 0 hr then at 12 hr and 24 hr. Total duration of treatment with injection is 24 hrs (3 times in 24 hrs during 28 days) |
| Intervention |
Novel formulation of Artesunate Injection |
Novel formulation of Artesunate Injection 2.4mg/kg body weight I.V. to be administered at 0 hr then at 12 hr and 24 hr.Total duration of treatment with injection is 24 hrs (3 times in 24 hrs during 28 days). |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects in the age range of 18-65 years (both inclusive)
2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
3. Patients with signs and symptoms of malaria and confirmation of diagnosis by positive blood smear test with asexual forms of Plasmodium falciparum with count equal to or more than 10,000 parasites per ul of blood and requiring parenteral therapy
4. Patient must understand and be able, willing, and likely to fully comply with study procedures and restrictions
5. Patient willing to come for study follow up as required by study protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients with febrile disease other than malaria
2. Patients with mixed malarial infections
3. Patient with severe malaria
4. Patients with abnormal heart function
5. Pregnant or lactating women.
6. Women of childbearing potential not practicing contraception.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cure Rate |
28-day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parasite Clearence Time |
Every 12 hours |
| Fever Clearence Time |
Every 6 hours |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/12/2010 |
| Date of Study Completion (India) |
22/12/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group multicenter trial comparing safety and efficacy of artesunate injection in the treatment of Plasmodium falciparum malaria. The primary efficacy outcome measure will be 28-day cure rate and the secondary efficacy outcome measure will be fever clearance time and parasite clearance time. |