| CTRI Number |
CTRI/2009/091/000872 [Registered on: 01/12/2009] |
| Last Modified On: |
04/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Visual Field Assessment With Subjects Who Receive Either Lyrica Or Sugar Pills |
Scientific Title of Study
Modification(s)
|
Prospective Randomized 12-Week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo |
| Trial Acronym |
Not applicable |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00351611 |
ClinicalTrials.gov |
| A0081096 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Karan Thakkar |
| Designation |
Site Oversight and Operations Relationship Lead |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901, Plot No.C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
91-7045788858 |
| Fax |
91-22-265225993 |
| Email |
Karan.Thakkar@Pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Seema Pai |
| Designation |
Director - Site Oversight and Operations Relationship Lead |
| Affiliation |
Pfizer Limited |
| Address |
Pfizer Limited,
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
91-8826422322 |
| Fax |
91-22-265225993 |
| Email |
seema.pai@pfizer.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Pfizer Limited, The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai - 400051, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Pfizer Limited |
| Address |
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai - 400051, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901, Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai - 400051, India. |
|
|
Countries of Recruitment
|
India
Bulgaria
Czech Republic
Hungary
Mexico
Poland
Republic of Korea
Thailand
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Chakor |
B.Y.L.Nair Hospital, T.N.Medical College |
B.Y.L.Nair Hospital, T.N.Medical College
Mumbai Central
Mumbai, Maharashtra 400008, INDIA
Mumbai
MAHARASHTRA |
02223027509
drchakorrt@yahoo.co.in |
| Dr Nadukuru Nooka Raju |
King George Hospital |
Department of Neurology,,Rajendra Prasad ward Maharani peta-530 002
Visakhapatnam
ANDHRA PRADESH |
91-984911505
91-89-12720698
drnnraju@yahoo.com |
| Dr Anu Radha Varalakshmi Elapavuluru |
Krishna Institute of Medical Sciences Ltd |
1 � 8 � 31 / 1, Minister Road, Secunderabad � 500 003
Andhra Pradesh, India
Rangareddi
ANDHRA PRADESH |
91-40-23543314
91-40-23350401
varalakshmiea@gmail.com |
| Dr R Srinivasa |
M.S Ramaiah Memorial Hospital |
M.S.R.I.T post,
New BEL Road,
Bangalore,Karnataka 500 054
INDIA
Bangalore
KARNATAKA |
09448040589
drrsrinivasa@hotmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Center |
Opposite Mallikatta Circle, Kadri, Mallikatta, Mangalore-575 002
Dakshina Kannada
KARNATAKA |
09845080925
918244255925
dr.shankaramnc@gmail.com |
| Dr Hemant Sant |
Sahyadri Speciality Hospital |
Plot No. 30C
Erandawane
Karve Road
Pune, Maharashtra 411004
INDIA
Pune
MAHARASHTRA |
91-9371008620
hmsant@gmail.com |
| Dr Gosala Raja Kukkuta Sarma |
St. Johns Medical College Hospital, |
John Nagar, ,Sarjapur Road, -560 034
Bangalore
KARNATAKA |
91-80-22065330
91-80-25634479
grk_sarma@yahoo.com |
| Dr Jaydip Ray Chaudhuri |
Yashoda Hospital |
Raj Bhavan Road, ,Somajiguda, -500 082,
Hyderabad
ANDHRA PRADESH |
91-40-23319999
91-40-23398667
jaydipsuvarna@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee for Dr. Anu Radha Varalaxmi |
Approved |
| Institutional Ethical Review Board, |
Approved |
| Institutional Ethics Committee for Dr. Venkateswarlu Kolichana |
Approved |
| Institutional Ethics Committee, B.Y.L.Nair Hospital, T.N.Medical College for Dr. Chakor |
Approved |
| Mangala Institutional Ethics Committee for Dr Shankara Nellikunja |
Approved |
| MS Ramaiah Medical College and Hospitals Ethical Review Board for Dr. Shrinivasa |
Approved |
| Sahyadri Ethics Committee for Dr. Hament Sant |
Approved |
| Yashoda Academy of Medical Educatrion & Research (YAMER) IEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Epilepsies, Partial, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Lyrica (pregabalin) |
150 mg twice a day, oral administration |
| Comparator Agent |
Placebo: Placebo Comparator
placebo comparator
Intervention Drug: placebo
|
twice a day, oral administration |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Ages Eligible for Study: 18 Years to 65 Years
b. Genders Eligible for Study: Both
c. Accepts Healthy Volunteers: No
1.Epilepsy partial seizure subjects.
|
|
| ExclusionCriteria |
| Details |
Pre-existing eye diseases. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Visual field changes, if there is any, while comparing before and after the study drug or placebo consumption will be assessed. |
3 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Visual acuity will be assessed at the beginning and end of the study as well. |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="284"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "183"
Final Enrollment numbers achieved (India)="29" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
22/12/2009 |
| Date of Study Completion (India) |
30/07/2019 |
| Date of First Enrollment (Global) |
01/07/2006 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Phase IV, multicenter, randomized placebo-controlled trial to further characterize visual fields in subjects with partial epilepsy dosed for 13 weeks, including a 1 week up titration and 1 week down titration from the target dose of pregabalin 300 mg/day versus placebo. Comprehensive ophthalmologic testing will be done at pre-treatment baseline to exclude those with pre-existing eye disease. |