| CTRI Number |
CTRI/2018/01/011465 [Registered on: 22/01/2018] Trial Registered Prospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative bioavailability study of Paliperidone Intramuscular Injection |
|
Scientific Title of Study
|
A randomized, single dose, balanced, multicenter, three-treatment, single period, parallel group, comparative bioavailability study of Paliperidone Intramuscular Injection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Patel |
| Designation |
Medical Advisor |
| Affiliation |
Wockhardt Ltd |
| Address |
NBCU Wockhardt Ltd
Wockhardt Hospital Campus
Wani House
Aurangabad
MAHARASHTRA
422001
India |
| Phone |
02536640600 |
| Fax |
|
| Email |
Nileshpatel@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Patel |
| Designation |
Medical Advisor |
| Affiliation |
Wockhardt Ltd |
| Address |
NBCU Wockhardt Ltd
Wockhardt Hospital Campus
Wani House
Aurangabad
MAHARASHTRA
422001
India |
| Phone |
02536640600 |
| Fax |
|
| Email |
Nileshpatel@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Patel |
| Designation |
Medical Advisor |
| Affiliation |
Wockhardt Ltd |
| Address |
NBCU Wockhardt Ltd
Wockhardt Hospital Campus
Wani House
Aurangabad
MAHARASHTRA
422001
India |
| Phone |
02536640600 |
| Fax |
|
| Email |
Nileshpatel@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Limited,
D-4, MIDC Area, Chikalthana,
Aurangabad-431 006
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Research Centre,
Wockhardt Limited.
D4 - MIDC Area, Chikalthana
Aurangabad-431006
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadeq Qureshi |
Axon Hospital |
Axon Hospital
first Floor Radiant Towers Gandhi Putla
Shahgunj Aurangabad
Aurangabad
MAHARASHTRA |
9923790591
q.sadiq12@gmail.com |
| Dr Manas Sule |
Dr.Manas Sule |
3, Avani Heights, Ist Floor Ahilya Dewi Holkar Marg,
Opp. Suyash Hospital/Tupaskhare Lawns, Mumbai Naka,
Nashik.
Nashik
MAHARASHTRA |
9552438444
dr.manas.sule@gmail.com |
| Dr Vaishal Vora |
Ratandeep Multispeciality Hospital |
5th Floor, Nakshatra Complex, Above HDFC Bank,
Maninagar Cross Road, Maninagar,
Ahmedabad-380008, Gujarat, India
Ahmadabad
GUJARAT |
07925463963
vnvora@gmail.com |
| Dr Vinay Barhale |
Shanti Nursing Home |
Shanti Nursing Home
Kanchan wadi Paithan Road
Aurangabad
Aurangabad
MAHARASHTRA |
02402379330
shantinursinghome79@gmail.com |
| Dr Amol Pathrikar |
Utkarsha Hospital |
Utkarsha Hospital
Plot no. 10, N-11/P, CIDCO
Harsul T- point, Beside HP Petrol Pump,
Jalgoan Road, Aurangabad
Aurangabad
MAHARASHTRA |
8888992688
drpathrikar1980@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee Ratandeep Multispeciality Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Invega Sustenna® (paliperidone palmitate) extended- release injectable suspension 156 mg |
Janssen Pharmaceuticals, Inc. USA |
| Intervention |
Test Product A-
WCK9003 Paliperidone Palmitate Intramuscular Injection 156 mg |
Wockhardt Limited, India |
| Intervention |
Test Product B-WCK9003 Paliperidone Palmitate Intramuscular Injection 156 mg |
Wockhardt Limited, India |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Written informed consent for participation in the study by the patient and patient’s legal acceptable representative (LAR).
2) Schizophrenic patients between 18.0 years and above.
3) Patients who are stabilized on Paliperidone extended release tablet 9mg once a day (atleast 8 consecutive doses before IP administration).
4) Patients have a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as confirmed by the investigator.
5) Not having any significant diseases or clinical significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluation, which may prevent to administer Paliperidone or Resperidone.
6) Able to comply with study procedures in the opinion of the investigator. |
|
| ExclusionCriteria |
| Details |
1) Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia.
2) History of neuroleptic malignant syndrome, tardive dyskinesia, or any malignancy.
3) Elderly patients with dementia-related psychosis treated with antipsychotic drugs
4) Patient on different antipsychotic treatment and unable to shift on Paliperidone oral therapy.
5) Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence.
6) Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study
7) Patient has taken the following prohibited medications: Strong CYP3A4/P-glycoprotein (P-gp) inducers (e.g., carbamazepine, rifampin, St John’s wort) barbiturates within 14 days prior to randomization.
8) Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
9) Patient with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
10) Personal / family history of allergy or hypersensitivity to Paliperidone or risperidone or its congeners or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator would compromise the safety of the patient or the study.
11) Evidence of impairment of renal, hepatic, cardiac, lungs or gastrointestinal function. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess bioavailability of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension of Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone. |
Pre-dose: 00 hours
Post-dose sample on day: 02, 04, 06, 08, 09, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24, 28.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor adverse events and ensure safety of the patients.
Exploratory Analysis of pharmacokinetic parameters.
|
NAP |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2018 |
| Date of Study Completion (India) |
28/06/2018 |
| 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
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A randomized, single dose, balanced, multicenter, three-treatment, single period, parallel group, comparative bioavailability study of WCK9003 Paliperidone Intramuscular Injection of Wockhardt Ltd., India compared with INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension of Janssen Pharmaceuticals, Inc. USA, in adult patient of Schizophrenia, stabilized with Paliperidone.
|