| CTRI Number |
CTRI/2010/091/001412 [Registered on: 11/10/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
|
Tapentadol Tablets in the Management of Acute Low Back Pain. |
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Scientific Title of Study
|
Comparative, Randomized, Double Blind, Parallel, Multicentric Study for Efficacy and Safety of Tapentadol Versus Tramadol In the Management of Acute Low Back Pain |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIMS - CPT HETERO / 10/ 03, Version-1 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shobha Jagadish Chandra |
| Designation |
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| Affiliation |
|
| Address |
Dept. of CP&T, Nizam's Institute of Medical Sciences
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
04023355600 |
| Fax |
04023355600 |
| Email |
jcshobha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shobha Jagadish Chandra |
| Designation |
|
| Affiliation |
NIMS |
| Address |
Dept. of CP&T, Nizam's Institute of Medical Sciences
Panjagutta
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
04023355600 |
| Fax |
04023355600 |
| Email |
jcshobha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
B Mohan Reddy |
| Designation |
|
| Affiliation |
|
| Address |
Hetero Drugs Ltd, Plot NO 80, 81
APIE Balanagar
Hyderabad
ANDHRA PRADESH
500037
India |
| Phone |
04023778611 |
| Fax |
04023778011 |
| Email |
b_mohanreddy@heterodrugs.com |
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Source of Monetary or Material Support
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| Hetero Labs Limited (Hyderabad) |
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Primary Sponsor
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| Name |
Hetero Labs Limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.D.Narayana Reddy |
Aakarsh Orthopedic Hospital |
16-2-87,Pogathota-524001
Nellore
ANDHRA PRADESH |
narayanareddyduvvuru@yahoo.co.in |
| Dr. Malhar Dave |
Abhishek Hospital |
Shivalik Comples, Subhanpura Mani Road,Subhanpura-390023
Vadodara
GUJARAT |
malhar.h.dave@gmail.com |
| Dr. J.L. Bassi |
Bassi Nursing Home Pvt. Ltd, |
Raj Pura Road,Civil Lines-141001
Ludhiana
PUNJAB |
jlbassi@gmail.com |
| Dr. Vipin Kumar Jain |
Clinic |
Janak,1/634 Vidhyadhar Nagar- 302023
Jaipur
RAJASTHAN |
jainvipin17@hotmail.com |
| Prof. A.K.Gupta |
GSVM Medical College |
L-26,Medical College Campus-208002
|
guptadrakg@rediffmail.com |
| Dr. A. Hanumantha Rao |
Hyma Hospitals |
Pattabhipuram,-522006
Guntur
ANDHRA PRADESH |
drahrao@yahoo.com |
| Dr.P. Ashok Kumar |
King George Hospital |
Andhra Medical College,King George Hospital-530002
|
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| Dr. Saurin Shah |
Parvati Jadav Hospital |
Near Bus Stop,Naroda-380025
Ahmadabad
GUJARAT |
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| Dr. Pabitra Kumar Sahoo |
SVNIRTAR |
Olatpur,Bairoi-754010
Cuttack
ORISSA |
pabitraindia@rediffmail.com |
| Dr Hitesh Panchal |
Trisha Trauma Centre |
A Block, Shantaram Complex,-
Ahmadabad
GUJARAT |
07927623762
hiteshpanchal77@yahoo.in |
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Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee for Dr Hitesh Panchal |
Submittted/Under Review |
| Clinicom Ethics Committee, Aakarsh Orthopedic Hospital For Dr. D. Narayana Reddy |
Approved |
| Clinicom Ethics Committee, Abhishek Hospital For Dr. Malhar Dave |
Approved |
| Clinicom Ethics Committee, Bassi Nursing Home Pvt. Ltd For Dr. J.L. Bassi |
Approved |
| Clinicom Ethics Committee, GSVM Medical College For Dr. A.K.Gupta |
Approved |
| Clinicom Ethics Committee, Hyma Hospitals For Dr. A. Hanumantha Rao |
Approved |
| Clinicom Ethics Committee, Parvati Jadav Hospital For Dr. Saurin Shah |
Approved |
| Clinicom Ethics Committee, S.K. Sony Hospital For Dr. Vipin Kumar Jain |
Approved |
| Clinicom Ethics Committee, SVNIRTAR For Dr. Pabitra Kumar Sahoo |
Approved |
| King George Hospital Ethics Committee, Andhra Medical College For Dr. P. Ashok Kumar |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Low Back Pain, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tapentadol 50mg |
Tapentadol 50mg, t.i.d daily, Duration 0,3,7 days |
| Comparator Agent |
Tramadol 50mg |
Tramadol 50mg, t.i.d daily, Duration 0,3,7 days |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Male or female patients
2.Age between 20-65 years
3.Willing to give written informed consent and willing to comply with study protocol.
4.Patients with acute or relapsing LBP moderate to severe intensity.
5.Patients with at least 40 mm pain intensity on VAS scale
6.Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
7.Patients not on any anti-inflammatory or other therapy for the past 2 weeks known to affect the study outcome.
|
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| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Patients with H/O any drug allergy
3.Severe spinal disease like spondylitis, fractures, cancer, severe arthrosis and osteoporosis.
4.Muscle diseases such as myositis, polymyositis, muscular dystrophy and myotony.
5.Unwilling to comply with the protocol requirements
6.H/o skin lesions, skin ulcers.
7.Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and faecal blood loss
8.Patients with cardiac, hepatic and renal dysfunction and haemopoetic disorder
9.Patients with hypertension
10.Patients deemed ineligible by the investigator |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in 1) pain (i.e. pain relief) (VAS), 2) Modified oswestry low back pain disability index (ODI) and 3) finger to floor distance from baseline. |
0,3,7 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary outcome is Global assessment by physician and patient. |
0,3,7 days |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
1. Comparative, Randomized, Double Blind, Parallel, Multicentric Study for Efficacy and Safety of Tapentadol Versus Tramadol In the Management of Acute Low Back Pain. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the Screening) and data will be submitted 200 completed patients. Study population will comprise of Patients with Acute Low Back Pain. 3. The recommended dose of Tapentadol 50mg tablets in comparison with Tramadol in the dose of 50mg t.i.d daily for 0,3,7 days. 4. The primary efficacy outcome will be Improvement in 1) pain (i.e. pain relief) (VAS), 2) modified Oswestry low back pain disability index (ODI) and 3) finger to floor distance from baseline and The Secondary outcome is Global assessment by physician and patient. |