| CTRI Number |
CTRI/2010/091/000245 [Registered on: 27/04/2010] |
| Last Modified On: |
31/07/2013 |
| 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 effect of primaquine conventional release tablet and primaquine sustained release tablet in prevention of relapse of plasmodium vivax malaria. |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy and Safety of Primaquine SR Tablets Vs Primaquine Conventional Tablets in the Prevention of Relapse of Plasmodium Vivax Malaria. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/MD/PRSR-07 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President - Medical Affairs and Clinical Research |
| Affiliation |
|
| Address |
142-AB
Kandivli Inductrial Estate
Kandivli West
Mumbai
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-61113150 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President - Medical Affairs and Clinical Research |
| Affiliation |
Ipca Laboratories Ltd. Mumbai |
| Address |
Ipca Laboratories Ltd.
Kandivali Industrial Estate, Kandivali (W)
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02266474444 |
| Fax |
02266474416 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitin Chandurkar |
| Designation |
General Manager |
| Affiliation |
|
| Address |
Plot 102, Ipca Laboratories Ltd.
Kandivali Industrial Estate, Kandivali (W)
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02261113101 |
| Fax |
02261113150 |
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Ltd. kandivali Industrial Estate Kandivali (w), Mumbai-400067 |
|
Primary Sponsor
Modification(s)
|
| Name |
Ipca Laboratories Ltd |
| Address |
142-AB, Kandivli Industrial Estate, Kandivli (W),
Mumbai - 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvind Kumar Jain |
Dr. S.N. Medical College and Hospital |
Department of Medicine, Shastri Nagar, Jodhpur- 342008
Jodhpur
RAJASTHAN |
9314743757
drarvindjain@gmail.com |
| Dr. Alaka Deshpande |
Grant Medical College and J.J. Group of Hospitals |
Byculla,-400 008
Mumbai
MAHARASHTRA |
9869168886
alakadeshpande@rediffmail.com |
| Dr. P.S. Karmakar |
IPGMER and SSKM Hospital |
A.J.C. Bose Road,-700 020
Kolkata
WEST BENGAL |
9332002930
parthamed@yahoo.co.in |
| Dr. A.R.Chogle |
Kasturba Hospital for Infectious Diseases |
Sane Guruji Marg,-400 011
Mumbai
MAHARASHTRA |
9821123184
02223092458
|
| Dr. D.K. Kochar |
Kothari Medical and Research Institute |
Kothari hospital Marg,Bangla nagar-334004
Bikaner
RAJASTHAN |
9351203902
drdkkochar@yahoo.com |
| Dr. Puneet Rijhwani |
Mahatma Gandhi Mission Medical College, Jaipur |
Sitapur Industrial Area, Jaipur,-302022
Jaipur
RAJASTHAN |
puneet284@rediffmail.com |
| Dr. A.L. Kakrani |
Padmashree, Dr. D.Y.patil Medical College and Hospital |
Sant Tukaram Nagar,Pimpri-411018
Pune
MAHARASHTRA |
9823972424
kakrani@hotmail.com |
| Dr. Nithya Gogtay |
Seth. G.S. Medical College and K.E.M. Hospital |
Department of Clinical Pharmacology,Parel-400012
Mumbai
MAHARASHTRA |
9820495836
njgogtay@hotmail.com |
| Dr. K.R.Lakshmi |
Siddhartha Medical College |
Siddhartha Medical College,-520008
|
9963186612
|
| Dr. Mala Kaneria |
T.N. Medical College and B.Y.L. Nair Hospital |
A.L. Nair Road,Mumbai Central-400 008
Mumbai
MAHARASHTRA |
9820210926
kaneriamala@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects, KEM Hospital |
Approved |
| Ethics Committee Sidhartha Medical College |
Not Applicable |
| Ethics Committee, Nair Hospital |
Approved |
| Institutional Ethics Committee, IPGMER |
Approved |
| Institutional Ethics Committee, JJ Hospital, Mumbai |
Approved |
| Institutional Ethics Committee, MGM Medical College, Jaipur |
Not Applicable |
| Institutional Ethics Committee,D.Y.Patil Medical College |
Approved |
| Kasturba Hospital Research Society, Ethics Committee for Research on Human Subjects |
Approved |
| Office of Department of Medicine, Dr. S. N. Medical College, Jodhpur |
Approved |
| Office of Ethics Committee, Kotahri Medical and Research Institute |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Plasmodium vivax malaria., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Primaquine conventional tablets |
15 mg, o.d. for 14 days |
| Intervention |
Primaquine Sustained Release Tablets |
15 mg and 30 mg tablet, o.d. for 14 and 7 days respectively |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Male and female patients aged 18 -65 years.2.Patients with confirmed cases of P. vivax malaria (asexual forms) by microscopy on a thin and thick blood smear with parasite count of >/=1,000/µL of blood.3.Patients with axillary temperature >/= 37.5 °C and with clinical signs and symptoms of malaria.4. Patients giving written informed consent to participate in this study.5.patients willing to undergo folloe-up for 2-6 months. |
|
| ExclusionCriteria |
| Details |
1. Patients with Mixed malarial infection.
2.Patients with body weight 40 kg.
3.Patients with severe or complicated malaria.
4.Patients with glucose 6-phosphate dehydrogenase deficiency.
5.Patients with a history of dark urine or significant hemoglobinuria related to Primaquine treatment during the course of a pervious episode of malaria.
6.Patient with known history of methomoglobinemia.
7.Patients taking cardioactive drug or potentially hemolytic drugs.
8.Patients with concomitant illness (cardiac, hepatic or renal diseases-blood urea nitrogen (BUN) 20mg/dl or blood urea 40mg/dl, hepatic SGPT or SGOT 2.5 x ULN, serum bilirubin 2mg/dl and serum creatinine 1.5mg/dl)).
9. Patients previously treated with any other antimalarial therapy except chloroquine.
10.Patients showing any significant abnormality (clinical or laboratory) on pre-trial screening in the opinion of the investigator.
11. Patients with protracted vomiting and oliguria.
12.Patients with systolic BP 160 mm Hg and/or diastolic BP 110 mm Hg.
13.Patients with acute exacerbations of systemic diseases, having a tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus.
14.Patients with underlying condition compromising bone marrow function or on medication which might compromise the bone marrow.
15.Patients with history of hypersensitivity to chloroquine, primaquine or aminoquinoline derivatives, or other similar drugs.
16. Patient having any concomitant medication which may interact with study drugs.
17.Patients on another investigational drug.
18. Patients unable to tolerate oral medication and known history of alcoholism.
19.Pregnant or lactating women.
20. Women of child bearing potential.
21.Patient with methomoglobinemia. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No occurrence of microscopically proven P. vivax malaria (asexual forms) after treatment with primaquine. |
Parasite count will be measured every 12 hours during 3 days of chloroquine therapy untill negative and then on day 7, 14, 21, 28 and then monthly up to 6 months. After day 14 parasite count will be measured only if the clinical signs and syptoms of malaria are present. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative safety |
At the end of therapy on day 14 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
16/08/2008 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Yet to be Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group, multicentre trial comparing the efficacy and safety of primaquine-Sr tablet and primaquine conventional release tablets in the preventiona of relapse P.vivax malaria in 360 patients that will be conducted at 7 centres in India. The primary efficacy outcome will be no occurenece of asexual forms of parasites in the blood 6 months after primaquine therapy. Secondary outcome will be occurence of parasites with syptoms of malaria after six months of primaquine therapy. |