| CTRI Number |
CTRI/2009/091/000434 [Registered on: 21/08/2009] |
| Last Modified On: |
24/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of artesunate - lumefantrine combination and artemether - lumefatrine combination in the treatment of uncomplicated Plasmodium falciparum malaria. |
Scientific Title of Study
Modification(s)
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Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed dose combination in the treatment of uncomplicated Plasmodium falciparum malaria. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| Ipca/ALFD/PIII-07 Version no. 2, Version date: 05/05/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
|
| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Medical Affairs & Clinical Research
142-AB, Kandivli Industrial Estate
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 |
General Manager |
| Affiliation |
Ipca Laboratories Ltd.,Mumbai |
| Address |
Clinical Research & Development
Plot No. 47, Kandivli Industrial Estate, Kandivli (W)
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-61112318 |
| Fax |
022-28686954 |
| Email |
nitin.chandurkar@ipca.com |
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Source of Monetary or Material Support
Modification(s)
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| Ipca Laboratories Ltd.,Mumbai |
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Primary Sponsor
Modification(s)
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| Name |
Ipca Laboratories Limited |
| Address |
142-AB, Kandivli Industrial Estate, Kandivli (W), Mumbai - 400 067. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
Modification(s)
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Countries of Recruitment
Modification(s)
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India |
Sites of Study
Modification(s)
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| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P B Gupta |
Government Medical College & New Civil Hospital, Surat |
Department of Medicine, New Civil Hospital, Majura Gate Surat-395001
Surat
GUJARAT |
9426854798
drpbgupta@gmail.com |
| Dr P S Karmakar |
Institute of Post Graduate Medical Education & Research |
4th floor Room No 2 Department of Medicine, Institute of Post Graduate Medical Education & Research and SSKM Hospital 244 AJC Bose Road Kolkata 700 020
Kolkata
WEST BENGAL |
09332002930
parthamed@yahoo.co.in |
| Dr Sangeeta Pednekar |
LTMMC & MGH, Mumbai |
Department of Medicine, LTMMC and LTMGH, Sion,Mumbai-400022
Mumbai
MAHARASHTRA |
9821577430
sjpednekar@hotmail.com |
| Dr Nilay Suthar |
Sheth Vadilal Sarabhai General Hospital |
Department of Medicine, Paldi Road Near Town Hall, Ellis Bridge,-380006
Ahmadabad
GUJARAT |
09825295840
nilay_suthar@yahoo.com |
| Dr Jitendra Lakhani |
Smt. B. K. Shah Medical College & Dhiraj General Hospital |
Department of Medicine, At and PO Piparia,Tal. Waghodia Dist. Vadodara,-391760
Vadodara
GUJARAT |
09974009181
jitendralakhani@doctor.com |
| Dr Vipul Srivastav |
Surat Municipal Institute of Medical Education & Research |
Ground Floor OPD Room No 1 Department of Medicine, SMIMER, Nr. Sahara Darwaja, Opp Bombay Market Umarwada,395010
Surat
GUJARAT |
09426891924
vipul_srivastav@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, GMC, Surat |
Approved |
| Institutional Ethics Committee, Institute of Post Graduate Medical Education & Research |
Approved |
| Institutional Ethics Committee, Surat Municipal Institute of Medical Education & Research |
Approved |
| LTMMC & MGH, Staff and Research Society |
Approved |
| Sheth VS General Hospital (Ethical Committee) |
Approved |
| Sumandeep Vidyapeeth University Institutional Ethics Committee For Human Research |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Uncomplicated Plasmodium falciparum malaria, |
|
Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Comparator Agent |
Artemether-Lumefantrine (Fixed-dose Combination Tablet) |
1 tablet at 0 hr, 8 hr, 24 hr, 36 hr, 48 hr and 60 hr |
| Intervention |
Artesunate-Lumefantrine (Fixed-dose combination tablet) |
1 tablet at 0 hr, 8 hr, 24 hr, 36 hr, 48 hr and 60 hr |
|
Inclusion Criteria
Modification(s)
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| Age From |
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| Age To |
|
| Gender |
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| Details |
1. Male and female patients with age between 18 to 65 years
2. Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P. falciparum (parasite count between 1000 and 100,000 asexual parasites/µL of blood)
3. Patients with axillary temperature >/= 37.5 °C and/or history of fever during past 24 hours
4. Patients with clinical signs and symptoms of malaria
5. Patients with satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe malaria as per WHO criteria
2. Patients with febrile disease other than malaria
3. Patients with mixed malarial infection
4. Patients with abnormal heart function including history of QTc prolongation
5. Patients receiving any concomitant medication which may interact with study drugs
6. Patients who had taken full course of antimalarials within previous 3 days
7. Patients with known history of hypersensitivity to any of the study related drugs
8. Pregnant or lactating women
9. Women of child bearing potential |
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
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Double Blind Double Dummy |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Adequate Clinical and Parasitological Response |
Day 28 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Parasite Clearance Time |
Day 1, Day 2 and Day 3 |
| Fever Clearance Time |
Day 1, Day 2 and Day 3 |
|
Target Sample Size
Modification(s)
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Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
30/07/2009 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Tropical Medicine and International Health 2013;8(5):578-587 |
|
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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This study is a randomised, double blind, parallel group, multicentre trial comparing the safety and efficacy of artesunate 100 mg + lumefantrine 480 mg with artemether 80 mg + lumefantrine 480 mg in the treatment of Indian patients with uncomplicated Plasmodium falciparum malaria. The patients will be hospitalized for 4 days. The follow up period is of 28 days. |