| CTRI Number |
CTRI/2016/08/007163 [Registered on: 08/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study in medical management of Neuropathic pain |
|
Scientific Title of Study
|
A prospective,randomized, comparative study of safety and efficacy of pregabalin, duloxetine, amitriptyline and pregabalin plus amitriptyline in neuropathic pain in a tertiary care hospital in West Bengal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sourav Chakrabarty |
| Designation |
Post-graduate trainee |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
R-33, Sagarbhanga colony, Durgapur, Burdwan,
POST-KENDUADIHI.
DIST-BANKURA.
PIN-722102
Bankura
WEST BENGAL
713211
India |
| Phone |
7602580581 |
| Fax |
|
| Email |
dr.souravchakraborty87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tamoghna Maiti |
| Designation |
Guide |
| Affiliation |
Bankura Sammilani Medical College |
| Address |
Suryakiran apartment, flat-31,
1A Umakanta Sen Lane,
Kolkata-30.
Kolkata
WEST BENGAL
700030
India |
| Phone |
9903425385 |
| Fax |
|
| Email |
dr.tamo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourav Chakrabarty |
| Designation |
student |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
R-33,Sagarbhanga colony, Durgapur, Burdwan
Kenduadihi,Bankura
PIN-722102
Bankura
WEST BENGAL
713211
India |
| Phone |
7602580581 |
| Fax |
|
| Email |
dr.souravchakraborty87@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sourav Chakrabarty |
| Address |
R-33,Sagarbhanga colony, Durgapur, Burdwan, West Bengal, PIN-713211 |
| Type of Sponsor |
Other [POST GRADUATE TRAINEE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sourav Chakrabarty |
Bankura sammilani medical college |
room no-1, outpatient division, department of neurology
Bankura
WEST BENGAL |
7602580581
dr.souravchakraborty87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitee, Bankura sammilani medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1)Diagnosed by consultant neurologist.
(2)Scoring ≥4 at DN4 Neuropathic pain diagnostic questionnaire
(3)Scoring ≥4 at Numeric pain rating scale at baseline presentation.
(4)Age 18-75 yrs.
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
(1)Diagnosed by consultant neurologist as having neuropathic pain.
(2)Scoring ≥4 at DN4 Neuropathic pain diagnostic questionnaire
(3)Scoring ≥4 at Numeric pain rating scale at baseline presentation.
(4)Age group 18-75 yrs.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
(1)Known serious spinal disease/bony deformity/vertebral fracture
(2)Abnormal renal function test.
(3)Cardiac conduction defect.
(4)Known allergy to any of the study medication.
(5)Benign Hyperplasia of prostate or H/O urinary retention.
(6)Pregnant& lactating mother.
(7)Patients taking MAO inhibitors.
(8)Inflammatory/Rheumatologic disorder.
(9)Suicidal tendency.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the drug with maximum efficacy in reducing neuropathic pain,as measured by Neuropathic pain symptom Inventory score(NPSI)in a treatment group. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the drug which causes maximum improvement of Quality of sleep as measured by The Pittsburgh Sleep Quality Index (PSQI)score. |
4 weeks |
Comparison of incidence of adverse drug reaction in each treatment groups.
|
4 wees |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/02/2015 |
| 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
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label, comparative, randomised, prospective
study will be conducted regarding the safety & efficacy of
Pregabalin,Duloxetine,Amitryptiline &Pregabalin plus Amitryptiline on
reducing neuropathic pain,due to various etiology,in patients of age group
18-75 yrs, attending Neurology OPD B.S.Medical college.Total duration of study
will be one year(Feb 2015-Jan 2016).Patients will be followed up for 4 weeks..We
will also assess the therapeutic safety
in each treatment groups and any associated adverse effects. Simultaneously we
will also assess the quality of improvement of sleep in each treatment
groups.The key objectives will be to find out the drug with maximum efficacy in
reducing neuropathic pain as well as in improving the quality of sleep in the
patients.We will also try to find out the drug with minimum adverse effects in
their respective study groups.The study will proceed after obtaining ethical
clearance from the institutional ethics committee. Before beginning the
interview, informed written consent will be taken from each participant.
|