| CTRI Number |
CTRI/2011/091/000010 [Registered on: 06/01/2011] |
| Last Modified On: |
20/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public 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 FDC Lornoxicam 8mg + Thiocolchicoside 8mg Capsule BID in Patients Suffering from 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 FDC Lornoxicam 8mg + Thiocolchicoside 8mg Capsule BID in Patients Suffering from skeletal Muscular spasm of any etiology. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/AL/CTIII-7721/12/2009 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Deepak Bhambe |
| Designation |
|
| Affiliation |
|
| Address |
NARENDRA PRAKASH HEALTHCARE CLINIC
DA/3-A,MAIN SHAKARPUR MARKET,OPP.NATHU SEETS.
New Delhi
DELHI
110092
India |
| Phone |
09654807949 |
| Fax |
|
| Email |
drdeepakbhambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
|
| Affiliation |
NEXUS CLINICAL RESEARCH (INDIA) LTD. |
| Address |
President & CEO
ANUJ PLOT NO-45,Ist FLOOR.MUMBAI PUNE HIGHWAY
Mumbai
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
022-27714207 |
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Vipul Gandhi |
| Designation |
|
| Affiliation |
|
| Address |
Head Business Development-Formulations,Alembic Ltd,
3rd Floor Alembic Road,
Not Applicable
N/A
390003.
India |
| Phone |
919727727402 |
| Fax |
|
| Email |
vipul.gandhi@alembic.co.in |
|
|
Source of Monetary or Material Support
|
| Alembic Ltd.
3rd Floor Alembic Road,
Baroda - Gujarat ,
INDIA 390003.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Alembic Ltd |
| Address |
3rd Floor
Alembic Road
Baroda-Gujarat
India 390003 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. SANDEEP BHALLA |
Dr Bhalla orthopedic clinic |
Site III/58, ,Vikas Puri,-110018.
New Delhi
DELHI |
09891425123
sbhalla22@gmail.com |
| DR. RAHUL NEHRA |
Hope Hospital |
200,,W.K.Road,-250 001.
|
09837052678
rahulnehra2001@yahoo.co.in |
| DR. VINOD KOLHE |
Kolhe orthopedic centre |
Shrikrupa, Near Police Station, , Akola Road, -444101
|
9881724232
drvinod.kolhe@gmail.com |
| DR. K.MOHAN PAI |
Mangalore Heart Centre |
No. 8, City Point,,Kodialbail,-575003.
Bangalore
KARNATAKA |
09854083135
mahanpaik@rediffmail.com |
| DR. DEEPAK BHAMBE |
Narendra Prakash Health Care Centre |
Narendra Prakash Health Care Centre, ,Laxmi Nagar, -110092.
New Delhi
DELHI |
09654807949
dr.deepakbhambe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients Suffering form Skeletal Muscular spasm of any etiology , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR |
once a day for 14 days |
| Comparator Agent |
FDC of Lornoxicam 8mg + Thiocolchicoside 8mg |
Twice a day for 14 days |
|
Inclusion Criteria
Modification(s)
|
| 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
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 UNL,
Clinically significant hepatic dysfunction defined by:
Total Bilirubin > 2 UNL
SGOT (AST) > 1.5 UNL
SGPT (ALT) > 1.5 UNL
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.
|
|
|
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 7 in both treatment groups. |
Baseline and completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 14 i.e. completion of protocol treatment in both treatment groups. |
Baseline and completion of treatment |
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/11/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
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 1week (Visit 2). At visit 3 efficacy and ADR evaluation will be done. At visit 4 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. |