| CTRI Number |
CTRI/2009/091/000970 [Registered on: 01/02/2010] |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized Factorial Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study of Flupirtine Maleate Vs Tramadol Hydrochloride in patients with acute & subacute pain |
Scientific Title of Study
Modification(s)
|
A phase III, multicentric, single blind, randomized, comparative study to assess the efficacy and safety of Flupirtine Maleate Vs Tramadol Hydrochloride in patients with acute & subacute pain. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LPL/AARPL/08/09/FP |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Neeraj Srivastava |
| Designation |
|
| Affiliation |
|
| Address |
Surgicare Clinic, 112, J.K. Chambers, Sector-17
Vashi
Mumbai
MAHARASHTRA
400703
India |
| Phone |
9820062580 |
| Fax |
|
| Email |
neerajanita22@yahoo.com.SG |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402200 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402200 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
|
|
Primary Sponsor
Modification(s)
|
| Name |
Lupin Ltd Mumbai |
| Address |
Laxmi Tower ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Aziz Mhate |
Mhate Clinic |
B3, Sector 2,Vashi-400703
Mumbai
MAHARASHTRA |
09820645023
draziz_mhate@yahoo.com |
| Dr P. Moralwar |
Moralwar Day Care Centre |
Sector 1, Near bank of India,CBD Belapur-400612
Mumbai
MAHARASHTRA |
022-27746464
psmoralwar@gmail.com |
| Dr. S.M. Akerkar |
Sawla nursing home |
Jivadaya lane,Ghatkopar(w)-400086
Mumbai
MAHARASHTRA |
09987027842
shashank77_2000@yahoo.com |
| dr.Ajit Nalwade |
Spandan Hospital & special Rheumatology Clinic |
3, Bhosle Garden,Solapur highway, hadapsar-411038
Pune
MAHARASHTRA |
020-64016412
dr_ajitnalawade@yahoo.co.in |
| Dr Neeraj Srivastava |
Surgicare Clinic |
112 J.K. Chambers, Sector 17,Vashi-400705
Mumbai
MAHARASHTRA |
022-27892793
neerajanita22@yahoo.com |
| Dr. Vinod Jain |
Vinod Hospital |
Near Laad Vanjari mangal Karyalay,NH6-425001
Jalgaon
MAHARASHTRA |
0257-2235658
drvinodj@rediffmail.com |
| Dr. N.j.S.Saggu |
Yash Speciality Clinic |
II Floor, 205 Nirman vypar Kendra,Sector 17, vashi-400705
Mumbai
MAHARASHTRA |
022-27660036
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
| DISHA INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute & subacute pain., |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Flupirtine Maleate |
? Flupirtine Maleate (100 mg) capsule will be administered orally thrice a day for 5- 7 days.
? The maximum dose that can be administered of Flupirtine Maleate will be 600 mg/day.
The dose administration will vary depending on the Investigator assessment and condition of Patient.
|
| Comparator Agent |
Tramadol Hydrochloride |
Tramadol Hydrochloride (50 mg) capsule will be administered orally thrice a day for 5- 7 days.
? The maximum dose of Tramadol Hydrochloride will be 400 mg/day.
? The dose administration will vary depending on the Investigator assessment and condition of Patient.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years2
Both genders2
Patient willing to follow up and willing to comply with procedures and requirements
Patient with signs & symptoms of acute, subacute pain, pain due to musculoskeletal condition, low back pain3, post operative pain, acute orthopedic conditions like bone fracture2
Patients who have received other medication for pain but having no improvement
|
|
| ExclusionCriteria |
| Details |
 Patients < 18 years and >65 years2
 Patients with hepatic encephalopathy.
 Patients suffering from myasthenia gravis.
 Patients with various liver disease
 Pregnant & lactating women2
 Orthopedic conditions showing degenerative changes
 Known hypersensitivity to the Flupirtine Maleate or Tramadol Hydrochloride
 Patients with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction2
 Participation in any other clinical trial in past 3 months
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy will be assessed by improvement in following parameters:
? Pain assessment (VAS )1
? Pain Relief Rate2
Based on a categorical transformation of the relative degree of pain relief rate :
 <25% = unrelieved
 25-49% = mere relief
 50-74% = moderate relief
 75-99%= significant relief
 100%= complete relief
|
5-7 DAYS |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Safety will be assessed based on analysis in the following variables:
? Adverse events
? Rescue medication
|
5-7 DAYS |
|
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)
|
10/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
trial not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It will be an open label, randomized trial involving minimum 200 PATIENTS WITH ACUTE AND SUBACUTE PAIN patients TO ASSESS THE SAFETY AND EFFICACY OF FUPIRTINE MALEATE VS TRAMADOL HYDROCHOLRIDE.DURATION OF TREATMENT WILL BE FIVE TO SEVEN DAYS PRIMARY OUTCOME OF THE TRIAL TO ASSESS AND COMPARE THE Pain (Visual Analog Scale )Pain Relief Rate ,SECONDARY OUTCOME IS TO ASSESS THE ADVERSE EVENT AND CONSUMPTION OF RESCUE MEDICATION FOR 7 DAYS |