| CTRI Number |
CTRI/2011/06/001794 [Registered on: 09/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
08/06/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF PHARMACOKINETICS (FATE OF DRUG IN THE BODY) OF SINGLE DOSE PRIMAQUINE (15 mg) IN PATIENTS WITH LIVER DYSFUNCTION |
|
Scientific Title of Study
|
EVALUATION OF PHARMACOKINETICS OF SINGLE DOSE PRIMAQUINE (15 mg) IN PATIENTS WITH HEPATIC DYSFUNCTION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Associate Professor |
| Affiliation |
NIL |
| Address |
Department of Clinical Pharmacology, 1st Floor, Multistorey Building, Seth GS Medical College and KEM Hospital, Parel,
Mumbai
NIL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-22-24174420 |
| Fax |
91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Associate Professor |
| Affiliation |
NIL |
| Address |
Department of Clinical Pharmacology, 1st Floor, Multistorey Building, Seth GS Medical College and KEM Hospital, Parel,
Mumbai
NIL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-22-24174420 |
| Fax |
91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Associate Professor |
| Affiliation |
NIL |
| Address |
Department of Clinical Pharmacology, 1st Floor, Multistorey Building, Seth GS Medical College and KEM Hospital, Parel,
Mumbai
NIL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-22-24174420 |
| Fax |
91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department Development Fund, Dept. of Clinical Pharmacology, Seth GSMC & KEM Hospital, Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Taur |
Department of Clinical Pharmacology |
Department of Clinical Pharmacology
1st Floor, New Multistorey Building, Seth GS Medical College and KEM Hospital. Parel,
Mumbai-400 012
Mumbai
MAHARASHTRA |
9920950564
912224112871
dr.santoshtaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee for Academic Research Ethics (CARE), Seth GSMC & KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with mild to moderate hepatic dysfunction (Modified Child-Pugh score 5-9), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
T. Primaquine |
15 mg single oral dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants classified by the Modified Child-Pugh Classification as having Grade A (mild) (Score of 5-6) or Grade B (moderate)(Score7-9) hepatic impairment
2. Participants with Normal Renal profile
3. Peripheral smear negative for malarial parasite
4. Willing to give written Informed Consent & comply with protocol requirement
|
|
| ExclusionCriteria |
| Details |
1. Participation in any clinical trial or investigational new drug study within 4 weeks prior to dosing.
2. Donation or loss of 300 mL or more of blood within 8 weeks prior to study start.
3. History of asthma and chronic obstructive pulmonary disease, treated or not treated or clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis)
4. Participants having WBC count of less than 3000/cmm
5. Any gastrointestinal disorder like diarrhea, constipation within 7 days before enrollment
6. G6PD deficiency
7. Known hypersensitivity to primaquine or related drugs (e.g., iodoquinol) as per history taking.
8. Persons receiving treatment with other potentially hemolytic drugs
9. Pregnancy (even if a pregnant woman is G6PD normal, the fetus may not be) & breast feeding women
10. Participants of Arthritis, Psoriasis, SLE, DLE
11. History of surgical portosystemic shunt. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| tmax, CMax, AUC0-t, AUC0-∞, Vd and t1/2 of Primaquine |
0 h (predosing) and 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 11, 12 and 24 h post dosing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Primaquine 15 mg single oral dose in patients with hepatic dysfunction |
Throughout the study and at 24 hours postdose |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primaquine has not been subjected to rigorous drug development processes that are in practice today. Thus use of primaquine in patients with hepatic dysfunction still remains empirical. This study aims to evaluate safety, tolerability and pharmacokinetics of single dose (15 mg) primaquine in patients with hepatic dysfunction.
|