| CTRI Number |
CTRI/2009/091/000953 [Registered on: 09/12/2009] |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An open label study to assess safety and tolerability of OPC-34712 in patients with schizophrenia. |
|
Scientific Title of Study
|
A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients with Schizophrenia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 331-08-210 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarathi Rajagopalan |
| Designation |
|
| Affiliation |
|
| Address |
Quintiles Research (India) Pvt Ltd.
301-A-1 Leela Business Park;Andheri (E)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
022 66774242 |
| Fax |
022 66774343 |
| Email |
Aarathi.rajagopalan@quintiles.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
|
Source of Monetary or Material Support
|
| Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Boulevard,
Rockville, Maryland 20850, United States
|
|
Primary Sponsor
Modification(s)
|
| Name |
Otsuka Pharmaceutical Development Commercialization |
| Address |
Inc 2440 Research Boulevard, Rockville, Maryland 20850, United States |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Shrinivasa Bhat |
Assitant Professor, Department of Psychiatry |
Justice K. S. Hegde Charitable Hospital,KSHEMA, Deralakatte-575018
Bangalore
KARNATAKA |
09845204136
0824 2202733
shrinivasabhat@yahoo.co.in |
| Dr. Sanjay Phadke |
Deenanath Mangeshkar Hospital & Research Center |
Erandawane,-411 004
Pune
MAHARASHTRA |
020 40151000
020 25420104
sanjay_phadke@hotmail.com |
| Dr. Sathianathan R |
Department of Psychiatry, Madras Medical College and Government General Hospital |
OP # 120,-600 003
Chennai
TAMIL NADU |
044 25388989
044 25388989
sathianathen6@yahoo.com |
| Dr. Venu Gopal Jhanwar |
Deva Mental Health Care |
B 27/70, MN, Durgakund,-221 005
Varanasi
UTTAR PRADESH |
0542 2312651
0542 2310510
venugj@gmail.com |
| Dr. Pradip Vaghasiya |
Gujarat Institute of Psychological Sciences and Research Center (GIPS) |
Shreenath Complex, Opp- Punit Nagar Society,Umiya Vijay Road-380015
Ahmadabad
GUJARAT |
079 26608485
079 26608498
pradip.gips@yahoo.com |
| Dr. Ravish Thunga |
Manaswini Thunga Institute of Psychiatry & Counselling |
Jyothi Circle,Balmatta-575 001
Bangalore
KARNATAKA |
manaswini_thunga@rediffmail.com |
| Dr. Mahesh Ramanna Gowda |
Spandana Research Centre |
No. 922, 2nd main,4th Block, Rajaji Nagar-Karnataka
Bangalore
KARNATAKA |
0866 2444999
0866 2444999
vishalindla@gmail.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health & Neurosciences |
29-7-32, V.V. Rao Street,-520002
|
080 23141027
08023141028
maheshrgowda@yahoo.com |
| Dr. Ravish Thunga |
Vinaya Hospital & Research Centre |
Post Box No. 717,Karangalpady-575 003
Bangalore
KARNATAKA |
0824 2443973
0824 2445034
manaswini_thunga@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Bangalore Medical College & Research Institute |
Submittted/Under Review |
| Central Ethical Committee |
Approved |
| DMHC Ethics Committee |
Approved |
| Ethics Committee of Vijayawada Institute of Mental Health & Neurosciences |
Approved |
| Independent Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Madras Medical College |
Submittted/Under Review |
| Mallikatta Ethical Committee |
Approved |
| Mallikatta Ethical Committee |
Submittted/Under Review |
| Sujlam Independent Ethics Committee |
Submittted/Under Review |
|
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
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
OPC-34712 |
1-6 mg/day, oral, for 6-week |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
2.Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
3.Subjects who participated in 331-07-203 and who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 for the treatment of schizophrenia. Eligible subjects include those who completed participation in the Treatment Phase of Protocol 331-07-203 (ie, Week 6 visit), including subjects who initiated open-label OPC-34712 as rescue therapy at Week 4 or Week 5.
4.Outpatient status at last visit of Protocol 331-07-203.
|
|
| ExclusionCriteria |
| Details |
1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
Target Disease, Medical History, and Concurrent Diseases
2.Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203.
3.Subjects who do not continue to meet all applicable inclusion/ exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
4.Subjects who represent a risk of committing suicide.
Prohibited Therapies or Medications
5.Subjects who would be likely to require prohibited concomitant therapy during the study
Other
6.Any subject who, in the opinion of the investigator, should not participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary evaluation of safety and tolerability will be through frequency and severity of AEs.
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in PANSS Total Score
Change from baseline in Clinical Global Impression - Severity of Illness scale (CGIS) score
Change from baseline in Personal and Social Performance scale (PSP) Total Score
Mean CGI-I score
Change from baseline in PANSS positive subscale score
Change from baseline in PANSS negative subscale score
Response rate, defined as reduction of ≥ 30% from baseline in PANSS Total Score OR CGI-I score of 1 (very much improved) or 2 (much improved) ? Discontinuation rate for lack of efficacy |
6 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="300"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
25/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
09/09/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
This will be a multicenter, 6-week, open-label study designed to assess the safety, tolerability, and efficacy of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. Enrollment into the study will be drawn from eligible subjects who have completed participation in Protocol 331-07-203 (CTRI/2009/091/000952) and who, in the investigator's judgment, could potentially benefit from treatment with oral OPC-34712 for schizophrenia. The study is to be conducted on an outpatient basis.
From India, 75 subjects will be screened. The tentative date of first patient enrollment in India is January 18, 2010.
|