| CTRI Number |
CTRI/2011/09/002015 [Registered on: 19/09/2011] Trial Registered Prospectively |
| Last Modified On: |
21/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients |
|
Scientific Title of Study
|
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245) |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A0081245 |
Protocol Number |
| NCT01271933 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Director-Compliance Oversight |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
|
|
Primary Sponsor
|
| Name |
Pfizer Limited |
| Address |
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Canada
India
Taiwan
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 Chandrashekara Srikatiah |
Chanre Rheumatology & Immunology Center & Research |
Department of Rheumatology, first floor#149, 15th Main Road, NHCL Water Tank Road, Bangalore, 560 079
Bangalore
KARNATAKA |
91-080-42516635
91-080-42516649
chandrashekara_s@yahoo.com |
| Dr Siddharth Das |
Chhatrapati Shahuji Maharaj Medical University |
Dept of Rheumatology, ground floor, RALC Campus, Lucknow- 226 018
Lucknow
UTTAR PRADESH |
0522-2614026
0522-2614026
das_lko@yahoo.com |
| Dr Rahul Kulkarni |
Deenanath Mangeshkar Hospital and Research Centre |
annexes building, 1st floor, Neurological Research department, Erandawane
Pune, Maharashtra 411 004
Pune
MAHARASHTRA |
91-020-66023000
91-020-66023107
rahulneuro@vsnl.net |
| Dr Harvinder Chhabra |
Indian Spinal Injuries Centre |
Chief of Spine Service &
Medical Director,
Sector- C, Vasant Kunj,
Opposite Vasant Valley School
New Delhi- 110070.
New Delhi
DELHI |
91-011-42255356
91-011-26898810
drhschhabra@isiconline.org |
| Dr Jugal Kishore Kadel |
Mahavir Hospital & Research Centre |
Ground floor, Room No. 411, Dept. of Rheumatology
10-1-1, Bhagwan Mahavir Marg
A.C. Guards, Hyderabad, 500 004
Hyderabad
ANDHRA PRADESH |
91-040-23320338
91-040-23320338
Jkishorek71@yahoo.co.in |
| Dr Balebail Dharmanand |
Manipal Hospitals |
Department of Rheumatology, Manipal Hospitals, ground floor, 98, HAL Airport Road, Bangalore, 560 017
Bangalore
KARNATAKA |
91-080-25024539
91-080-25207181
bgdharmanand@hotmail.com |
| Dr Parshant Aggarwal |
Punjab Rheumatology Centre |
Ground floor, 96-B, Rajguru Nagar, Ferozepur road, Ludhiana
Ludhiana
PUNJAB |
0161-3230943
drparshant@gmail.com |
| Dr Hemant Sant |
Sahyadri Speciality Hospital |
Neurology Department, 1st floor, room no 112,
30C, Erandawane
Karve Road
Pune, Maharashtra 411 004
INDIA
Pune
MAHARASHTRA |
91-020-25403000
91-020-25459117
hmsant@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| DORAHA, Ludhiana for Dr Parshant Aggarwal |
Approved |
| Ethics Committee of Manipal Hospital and Manipal Heart Foundation |
Approved |
| Institutional Ethics Committee CRICR Chanre Rheumatology & Immunology Center & Research |
Approved |
| Institutional Ethics Committee for Biomedical Research Bhagwan Mahavir Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Indian Spinal Injuries Centre |
Approved |
| Institutional Ethics Committee, Office of the Research Cell Chhatrapati Shahuji Maharaj Medical University |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre |
Approved |
| Sahyadri Hospitals Limited Ethics Committee, Sahyadri Speciality Hospital, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Comparator |
Drug: placebo
matching placebo tablet; given once daily
|
| Intervention |
Pregabalin-Experimental
Intervention
|
Drug: pregabalin
controlled release tablet; 165-495 mg/day (Starting dose of 165 mg/day escalated up to 495 mg/day); given once daily
Route: oral, Total duration of thearapy is 20 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients must have fibromyalgia.
|
|
| ExclusionCriteria |
| Details |
Patients with other painful conditions cannot participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to loss of therapeutic response based on pain response relative to baseline or patient discontinuation |
19 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Daily pain diary |
throughout study |
| 2. Daily tiredness diary |
throughout study |
| 3. Daily sleep diary |
throughout study |
| 4. Numeric rating scale for pain |
screening, baseline, 6 and 19 weeks |
| 5. Medical outcomes sleep study-sleep scale |
baseline, 6 and 19 weeks |
| 6. Patient global impression of change |
baseline, 6 and 19 weeks |
| 7. Short form 36 health survey (SF-36) |
baseline, 6 and 19 weeks |
| 8. Hospital anxiety and depression scale |
baseline, 6 and 19 weeks |
| 9. Fibromyalgia impact questionnaire |
baseline, 6 and 19 weeks |
| 10. Multidimensional fatigue instrument |
baseline, 6 and 19 weeks |
| 11. Benefit, satisfaction, willingness to continue measure |
baseline, 6 and 19 weeks |
| 12. Work productivity and activity impairment |
baseline, 6 and 19 weeks |
| 13. Actigraphy functional / sleep assessment |
screening, 3 and 11 weeks |
| 14. Adverse events, suicidality assessment |
throughout study |
| 15. Clinical laboratory tests, ECG, physical / neurological examinations, weight assessment, and vital signs |
screening, 6 and 19 weeks |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/03/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a phase 3 double blind , randomized, placebo controlled trial to evaluate the safety and efficacy of once daily controlled release pregabalin in treatment of patients with fibromyalgia. The starting dose is 165 mg/day and can be escalated at weekly intervals up to 495 mg/day on the basis of efficacy and tolerability. The study will be composed of 4 phases: baseline (1 week), single blind (6 weeks), double-blind treatment (13 weeks), and a 1-week double-blind taper. This study will have 2 arms in the double-blind phase:
1. Pregabalin (CR).
2. Matching placebo
This study will use a randomized withdrawal (RW) trial design. The RW design includes 2 phases: a single-blind pregabalin treatment phase and a double-blind randomized withdrawal phase.
|