| CTRI Number |
CTRI/2010/091/000009 [Registered on: 07/01/2010] |
| 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 + Chlorzoxazone Tablets in the treatment of Acute Musculoskeletal Pain. |
|
Scientific Title of Study
|
Comparative, Randomized, Open Label, Parallel, Multicentric study for Efficacy and Safety of Lornoxicam + Chlorzoxazone versus Lornoxicam in the Management of Acute Musculoskeletal Pain. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPT-NIMS - HETERO / 08/ 15 |
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
Punjagutta
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
Punjagutta
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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Primary Sponsor
|
| Name |
Hetero Labs Limited |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Malhar Dave |
Abhishek Hospitals |
Shivalik Comples,Subhanpura Mani Road, Subhanpura-390023
Vadodara
GUJARAT |
0265-2290102, 2292166.
malhar.h.dave@gmail.com |
| Dr. J.L. Bassi |
Bassi Nursing Home Pvt. Ltd |
Raj Pura Road,Civil Lines-
Ludhiana
PUNJAB |
0161-2301133
jlbassi@gmail.com |
| Dr. Surgeon G.P. Bhargava |
Brahmesh Orthopaedic & Trauma Centre |
Kala Bhawan ,6 Newul Kishore Road-226 001
Lucknow
UTTAR PRADESH |
2287456, 2202857
gp_bhargava@hotmail.com |
| Dr.K.R.Sreenadh |
C.AM.Hospital |
Olarikkara,-680012
|
krsreenath@gmail.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@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
drahrao@yahoo.com |
| Dr. R. Jayakumar |
Kavya Ortho Center |
,-641 004
Coimbatore
TAMIL NADU |
jljk71@yahoo.co.in |
| Dr. B. Udayakumar |
King George Hospital |
,-
Visakhapatnam
ANDHRA PRADESH |
0891-2563344
kumar.udaya52@yahoo.com |
| Dr. Babu Joseph |
M.A.J Hospital |
Edappally,-682024
|
484- 2335996 / 2346996
babu_j@bsnl.in, babujoseph8@gmail.com |
| Dr. Sanjay Kumar Das |
S.V. Nirtar Olatpur Hospital |
,-
Cuttack
ORISSA |
sanjayadasnirtar@yahoo.com |
| Dr. S. Suresh Reddy |
S.V.R.R. Govt. Gen. Hospital |
,-
|
0877-2229225
srisurdr@yahoo.co.in |
| Dr. N. Balamurugan |
Sri Gokulam Hospital |
3/60, Meyyanyr Road ,-
Salem
TAMIL NADU |
0427 - 2448171
baluneuro@yahoo.co.in |
| Dr. Pabitra Kumar Sahoo |
SVNIRTAR, Olatpur |
Bairoi,-754010
Cuttack
ORISSA |
pabitraindia@rediffmail.com |
| Dr. Janardhana Aithala |
TMA Pai Hospital |
,-
Udupi
KARNATAKA |
janardanaaithala@yahoo.com |
| Dr. Balvir Singh Virk |
Virk Hospital |
Randhir Lane,Dayal Singh College-
Karnal
HARYANA |
0184-2270332
balbir_virk@yahoo.co.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee For Abhishek Hospitals |
Approved |
| Clinicom Ethics Committee For Bassi Nursing Home |
Approved |
| Clinicom Ethics Committee For Brahmesh Orthopaedic & Trauma Centre |
Approved |
| Clinicom Ethics Committee For C.AM.Hospital |
Approved |
| Clinicom Ethics Committee For Dr. Janardhana Aithala, TMA Pai hospital |
Approved |
| Clinicom Ethics Committee For Dr. N. Balamurugan |
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 M.A.J Hospital |
Approved |
| Clinicom Ethics Committee For S.V. Nirtar Olatpur Hospital |
Approved |
| Clinicom Ethics Committee For SVNIRTAR, Olatpur |
Approved |
| Clinicom Ethics Committee For Virk Hospital |
Approved |
| Ethics committee of Nizam's Institute of Medical Sciences, Hyderabad |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Musculoskeletal Pain , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A FDC of Lornoxicam 4mg + Chlorzoxazone 250mg |
Lornoxicam 4mg + Chlorzoxazone 250mg,TID, Duration one week |
| Comparator Agent |
Lornaxicam 4mg |
Lornaxicam 4mg,TID, Duration one week |
|
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Inclusion Criteria
|
| Age From |
|
| 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.
|
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| 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 h)H/O skin lesions, skin ulcers |
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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 |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy outcome will be Change in pain rating, tenderness and pain relief from baseline to end of the study (0-7days) |
0,3 & 7 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 days |
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Target Sample Size
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Total Sample Size="240"
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) |
18/01/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="4"
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 + Chlorzoxazone versus Lornoxicam in the Management of Acute Musculoskeletal Pain. 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 Acute Musculoskeletal Pain. 3. The recommended dose of Lornoxicam in dose of 4mg + Chlorzoxazone in dose of 250mg in comparison with Lornoxicam in the dose of 4mg thrice daily for one week. 4. The primary efficacy outcome will be Change in pain rating, tenderness and pain relief 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. |