| CTRI Number |
CTRI/2012/02/002440 [Registered on: 22/02/2012] Trial Registered Prospectively |
| Last Modified On: |
21/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial of Fixed Dose Combination of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet OD Compared with Thiocolchicoside 8mg Capsule BID in Patients Suffering pain associated with Skeletal Muscular Spasm of any etiology. |
|
Scientific Title of Study
|
A Control- Labeled, Prospective, Randomized, Parallel Group, Multicentric, Phase III Clinical trial to Evaluate Efficacy and Safety of a FDC of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet OD Compared with Thiocolchicoside 8mg Capsule BID in Patients Suffering pain associated with Skeletal Muscular Spasm of any etiology |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/INV/CTIII-7726/03/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Bhambe |
| Designation |
Consultant Physician |
| Affiliation |
NARENDRA PRAKASH HEALTHCARE CENTER |
| Address |
DA-3/A, MAIN SHAKAR PUR,
OPP NATHU SWEETS,
BEHIND POLICE BOOTH,LAXMINAGAR,
DELHI.
New Delhi
DELHI
110092
India |
| Phone |
09654807949 |
| Fax |
|
| Email |
dr.deepakbhambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
NEXUS CLINICAL RESEARCH (INDIA) LTD. |
| Address |
32A, Nexus Centre for Clinical Excellence, Shiravane Road,
Service Industry, Sector-1, Mumbai-Pune Highway,
Nerul (E), Navi Mumbai.
Raigarh
MAHARASHTRA
400 706
India |
| Phone |
022-27714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Gangadhar Hulsure |
| Designation |
Scientist FRD |
| Affiliation |
Inventia Health Care Pvt. Ltd. |
| Address |
505, VIP plaza, Veera Industrial Estate, Link Road, Andheri (W), Mumbai.
Mumbai
MAHARASHTRA
400 053
India |
| Phone |
022-67163466 |
| Fax |
|
| Email |
gangadhar.hulsure@inventiahealthcare.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Pvt Ltd |
| Address |
A/505, Veera Industrial Estate,
Off. Infinity Mall, Andheri Link Road,
Andheri (W), Mumbai - 400053.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tarsem Motten |
District Hospital |
District Hospital, Poonch,Jammu-180001.
Jammu
JAMMU & KASHMIR |
09419101542
drtarsemmoten@yahoo.in |
| Dr Rahul Nehra |
Dr. Nehras Orthopaedics and Trauma Centre |
20/21, Tyagi Hostel Complex, W. K. Road, Meerut-250 001.
Meerut
UTTAR PRADESH |
09837052678
rahulnehra2001@yahoo.co.in |
| Dr Tanuraj Sirohi |
Hope Hospital |
200, W. K. Road, Meetut- 250 001.
Meerut
UTTAR PRADESH |
09837020820
trsirohi@yahoo.com |
| Dr Deepak Bhambe |
NARENDRA PRAKASH HEALTHCARE CENTER |
DA-3/A, MAIN SHAKAR PUR,
OPP NATHU STWEETS,
BEHIND POLICE BOOTH,LAXMINAGAR,
DELHI-110092.
New Delhi
DELHI |
09654807949
dr.deepakbhambe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Hope Hospital Institutional Ethics Committee, Meerut. UP(Dr Rahul Nehra and Dr Tanuraj Sirohi) |
Approved |
| Human Rights and Ethics Committee, Jammu.( Dr Tarsem Motten) |
Approved |
| The Central Independent Ethics Comittee Clinical Research (India), Delhi.( Dr Deepak Bhambe) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain associated with Skeletal Muscular Spasm of any Etiology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Lornoxicam + Thiocolchicoside Tablet |
Fixed Dose Combination of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet Once a day orally for 7 days. |
| Comparator Agent |
Thiocolchicoside Capsule |
Thiocolchicoside 8mg Capsule Twice a day orally for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Non specific skeletal muscular spasm, with an acute episode.
Recent onset (<48 hours) defined by average pain and local immobility within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS)
Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Acute pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders.
Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain ( Annexure –V)
History of inflammatory arthritis of large joints.
History of seizure disorders.
History of malignant tumor.
Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids.
Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission,
Psychiatric or mental diseases.
Immune Compromised HIV.
Inclusion in another study in the past six months or previous inclusion in this study,
History of alcohol, drugs or narcotics abuse.
Recent history of violent trauma.
Constant progressive, non mechanical pain (no relief with bed rest).
Thoracic pain.
Patient systemically unwell.
Unexplained weight loss.
Widespread neurological symptoms (including Cauda equine syndrome).
Structural deformity.
Fever.
Clinical significant renal dysfunction defined by Creatinine > 1.5 mg/dl
Clinically significant hepatic dysfunction defined by:
Total Bilirubin > 2 mg/dl
SGOT (AST) > 1.5 IU/L
SGPT (ALT) > 1.5 IU/L
Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours.
Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
Known or suspected hypersensitivity to Thiocolchicoside and Lornoxicam. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups. |
At day 4 of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups. |
At day 7 of the treatment |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test. Enrolled subjects will receive the medication for 4 days(Visit 2). At visit 3 (day 4) efficacy, ADR evaluation and drug dispensing for next visit will be done. At visit 4 (day 7) end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study. |