| CTRI Number |
CTRI/2009/091/000794 [Registered on: 19/11/2009] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Lornoxicam + Eperisone Tablets in the treatment of Cervical Spondylosis. |
|
Scientific Title of Study
|
Comparative, Randomized, Open Label, Parallel, Multicentric Study for Efficacy and Safety of Lornoxicam+ Eperisone versus Lornoxicam in Management of Cervical Spondylosis. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPT-NIMS - HETERO / 08/ 16 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shobha Jagadish Chandra |
| Designation |
|
| 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 Balanager
Hyderabad
ANDHRA PRADESH
500037
India |
| Phone |
04023778611 |
| Fax |
04023778011 |
| Email |
b_mohanreddy@heterodrugs.com |
|
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Source of Monetary or Material Support
|
| Hetero Labs Limited (Hyderabad) |
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Primary Sponsor
|
| 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
|
| No of Sites = 13 |
| 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 |
0861-2332070
aakarsh_heman@yahoo.co.in |
| Dr. Malhar Dave |
Abhishek Hospital |
Shivalik Complex,-390023
Vadodara
GUJARAT |
abhishekhospital@yahoo.com |
| Dr.U.Shobha Jagadish Chandra |
Dept of Clinical Pharmacology and Therapeutics |
Nizam's Institute of Medical Sciences ,Punjagutta-500082
Hyderabad
ANDHRA PRADESH |
04023355600
04023355600
jcshobha@rediffmail.com, jcshobha@yahoo.com |
| Dr. V.J. Senthil |
G.V.N Hospital |
46, Singarathope,-620008
|
0431-2700811/2700712
vjsenthil@hotmail.com |
| Dr. A. Hanumantha Rao |
Hyma Hospitals |
Pattabhipuram,-522006
Guntur
ANDHRA PRADESH |
(863)- 2231564 / 2251504/ 2230020
drahrao@yahoo.com |
| Dr. R. Jayakumar |
Kavya Ortho Center |
,-641 004
Coimbatore
TAMIL NADU |
jljk71@yahoo.co.in |
| Dr. Eswara Babu |
King George Hospital |
,-
Visakhapatnam
ANDHRA PRADESH |
9246627585
eswarortho85@hotmail.com |
| Dr. S. Suresh Reddy |
S. V. R. R. Govt. Gen. Hospital |
,-
|
9247319150
srisurdr@yahoo.co.in |
| Dr. Sanjay Kumar Das |
S.V. Nirtar Olatpur Hospital |
,-
Cuttack
ORISSA |
sanjayadasnirtar@yahoo.com |
| Dr. Vincent K. Chakkiah |
Sanjoe Hospital |
Ernakulam Dt,-
|
484-2522263
vinckay@yahoo.com, vinckay@gmail.com |
| Dr. N. Balamurugan |
Sri Gokulam Hospital |
3/60, Meyyanyr Road,-
|
0427 - 2448171 - 76, 2449965
baluneuro@yahoo.co.in |
| Dr. Janardhana Aithala |
TMA Pai Hospital |
TMA Pai Hospital ,-
Udupi
KARNATAKA |
janardanaaithala@yahoo.com |
| Dr. S. Sundar |
V.S.Hospital |
13, East Spurtank RD,,Chetpet-
|
044-42001000
drsundar69@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee For Aakarsh Orthopedic Hospital |
Approved |
| Clinicom Ethics Committee For Dr. N. Balamurugan |
Approved |
| Clinicom Ethics Committee For Dr. S. Sundar |
Approved |
| Clinicom Ethics Committee For Dr. S. Suresh Reddy |
Approved |
| Clinicom Ethics Committee For G.V.N Hospital |
Approved |
| Clinicom Ethics Committee For Hyma Hospitals |
Approved |
| Clinicom Ethics Committee For Kavya Ortho Center |
Approved |
| Clinicom Ethics Committee For S.V. Nirtar Olatpur Hospital |
Approved |
| Clinicom Ethics Committee For Sanjoe Hospital |
Approved |
| Clinicom Ethics Committee For Abhishek Hospital |
Approved |
| Ethics committee of Nizams Institute of Medical Sciences, Hyderabad |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Manipal University Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical Spondylosis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A FDC of Lornaxicam 4mg + Eperisone 50mg |
Lornaxicam 4mg + Eperisone 50mg,TID, Duration 2weeks |
| Comparator Agent |
Lornaxicam 4mg |
Lornaxicam 4mg,TID, Duration 2weeks |
|
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Inclusion Criteria
|
| Age From |
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| Age To |
|
| Gender |
|
| Details |
a) Male or female patients
b) Between 20-65 years of age
c) Willing to give written informed consent and willing to comply with trial protocol.
d) Out patients with diagnosis of cervical spondylosis.
e) Patients with at least 40 mm pain rating on VAS scale.
f) Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
g) Patients not on any anti-inflammatory or other therapy in the past 2 weeks known to affect the study outcome.
|
|
| ExclusionCriteria |
| Details |
a) Pregnant and lactating women
b) Patients with H/O any drug allergy
c) Unwilling to comply with the protocol requirements
d) Patients with gastro-intestinal disease, peptic ulcer,
bleeding disorder and fecal blood loss.
e) Patients with cardiac, hepatic, renal dysfunction and
haemopoetic disorder
f) Patients with hypertension
g) Patients deemed ineligible by the investigator |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy outcome will be change in pain, neck stiffness and range of neck movement from baseline to end of the study (0-14days) |
0,3,7 & 14 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study |
0,3,7 & 14 days |
|
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Target Sample Size
|
Total Sample Size="230"
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 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
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.This is a Comparative, Randomized, Open Label, Parallel, Multicentric Study for Efficacy and Safety of Lornoxicam+ Eperisone versus Lornoxicam in Management of Cervical Spondylosis.
2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the expected no. of dropouts) and data will be submitted 240 completed patients. Study population will comprise of Patients with Cervical Spondylosis.
3.The recommended dose of Lornoxicam in dose of 4mg + Eperisone in dose of 50mg in comparison with Lornoxicam in the dose of 4mg thrice daily for 2 weeks.
4.The primary efficacy outcome will be change in pain, neck stiffness and range of neck movement from baseline to end of the study and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study. |