| CTRI Number |
CTRI/2011/091/000140 [Registered on: 01/02/2011] |
| Last Modified On: |
14/11/2018 |
| 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 to assess effectiveness and safety of two medications for the treatment for schizophrenia |
Scientific Title of Study
Modification(s)
|
A randomized, open label, comparative, multicentric, phase 3 clinical study to assess the efficacy and safety of Blonanserin tablets in comparison with Haloperidol tablets in patients suffering from schizophrenia |
| Trial Acronym |
None |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868211 |
| Fax |
079-26862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| None |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Anand |
Anand Hospital, Gandhinagar |
Anand Hospital, GH-4, Sector 16, Gandhinagar
Gandhinagar
GUJARAT |
079-23238853
drrajendraanand@yahoo.com |
| Dr Bhavesh Lakdawala |
B.J. Medical College & Civil Hospital, Ahmedabad |
Department of Psychiatry, B.J. Medical College & Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT |
079-22683721
dr_bmlakdawala@yahoo.co.in |
| Dr Vijay Nagecha |
Nagecha Hospital, Rajkot |
Nagecha Hospital, Creative Chambers, Opposite Hotel Ruby, Behind Bus Stand, Kanak Road, Rajkot.
Rajkot
GUJARAT |
0281-2222224
nagecha@rediffmail.com |
| Dr Lakshman Dutt |
Shri Krishnaprasad Psychiatric Nursing Home & Research Centre |
111, Shriji complex,Behind V.S. Hospital, Ellisbridge-380006
Ahmadabad
GUJARAT |
079-26588055
lakshmandutt1@indiatimes.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC - Aditya for Dr. Lakshman Dutt |
Approved |
| IEC - Aditya for Dr. Rajendra Anand |
Approved |
| IEC - Aditya for Dr. Vijay Nagecha |
Approved |
| Institutional Ethics Committee - B.J. Medical College & Civil Hospital, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Schizophrenia, (1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Blonanserin tablets |
1 tablet twice daily after meals for entire study period |
| Comparator Agent |
Haloperidol tablets |
1 tablet thrice daily for entire study period |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18-65 years of age.
2. Patients with diagnosis of schizophrenia.
3. Informed consent. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and/or lactation.
2.Patients with suicidal tendencies.
3.Patients with relevant CNS disorders or history of such disorders.
4.Patients with a history of neuroleptic malignant syndrome (NMS).
5.Patients with uncontrolled diabetes or significant cardiovascular diseases.
6.Patients with angle-closure glaucoma, benign prostatic hyperplasia, urinary retention or paralytic ileus.
7.Patients with significant renal or hepatic impairment, acute infections, leucopenia, hyperthyroidism or SIADH.
8.Impoverished patients.
9.Patients with an organic psychiatric disorder.
10.History of hypersensitivity to study medication.
11.Patients requiring concomitant treatment which is not permissible.
12.Patients with any other serious concurrent illness or malignancy.
13.Patients with continuing history of alcohol and/or drug abuse.
14.Participation in another clinical trial in the past 3 months. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of improvement in the PANSS total score |
Baseline, monthly & at the end of study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) The degree of improvement in the PANSS factor scores
(2) The degree of improvement in the Clinical Global Impressions (CGI) ? severity and improvement scores |
Baseline, monthly & at the end of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
27/01/2011 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
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, open label, active controlled, multicentric study comparing the safety and efficacy of Blonanserin twice daily and Haloperidol thrice daily in 200 patients with schizophrenia that will be conducted in India. The primary outcome measures will be the change in the PANSS score. |