| CTRI Number |
CTRI/2010/091/000169 [Registered on: 25/03/2010] |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the efficacy and safety of alpha,beta-arteether in patient of P. falciparum malaria. |
Scientific Title of Study
Modification(s)
|
A Phase III, Multicenter, Open Label, Randomized, Single Treatment study to evaluate the efficacy and safety of alpha,beta - arteether injection 150 mg/mL in patient of P. falciparum malaria. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Protocol No. ECTS/09/005 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, devipark
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, devipark
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
11, devipark
B/h Lake View Appt., Vastrapur
Ahmadabad
GUJARAT
380054
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Lincoln Pharmaceuticals Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Lincoln Pharmaceuticals Ltd |
| Address |
10, 12, 13 Trimul Estate,
Nr. Khatraj chokadi, Khatraj-382721, Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Pawan Kumar Kashyap |
Combine Hospital |
Combine Hospital,Dist. Chandauli-
|
+919198246606
|
| Dr. Akhil Mukim |
Mukim Medical and Nursing Home and Heart Clinic |
Bodakdev,-380054
Ahmadabad
GUJARAT |
07926853785
drmukim@indiatimes.com |
| Dr M L Shukla |
Shuklas Hospital |
Nr Alankar Cinema, M.G.Road, Bardoli-394601
Surat
GUJARAT |
02622-220235
drshukla99@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Akhil Mukim |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Mahesh L. Shukla |
Approved |
| Independent Ethics Committee - Aditya, Ahmedabad for Dr. Pawankumar Kashyap |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B509||Plasmodium falciparum malaria, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Arteether Injection |
One injection once daily for atleast three days |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
76.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent from the patient.
2.Male and Female patients with aged 18 years above inclusive.
3. Diagnosis of Patients with P. falciparum malaria by the presence of ring forms of P. falciparum in thick and thin peripheral blood smears (parasitemia > 5%). |
|
| ExclusionCriteria |
| Details |
1. Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
2. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
3. Known hypersensitivity to alpha,beta-arteether.
4. Patient with renal failure and other systemic disorder.
5. Patient who is consuming/ has received drugs, which have interaction with alpha,beta-arteether, during last 14 days.
6. Participation in any other clinical trial during last 30 days.
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean Cure rate |
after 3 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Parasite clearance time |
Based on blood smear test after drug administration of 24 hours, 48 hours and 72 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "199"
Final Enrollment numbers achieved (India)="199" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/02/2010 |
| Date of Study Completion (India) |
25/02/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a phase III multicenter open label single treatment studyto evaluate the efficacy and safety of Arteether injection in patients with Falciparum malaria. Selected patients based on the inclusion exclusion criteria will be adminisatered three doses of arteether 150mg injection every 24 hrs. Blood smear will be examined for P. falciparum positive or negative. Based on the results, efficacy will be decided. |