| CTRI Number |
CTRI/2011/091/000009 [Registered on: 07/01/2011] |
| Last Modified On: |
21/03/2013 |
| 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 Comparative, Randomized Parallel group, Multicentric Prospective Phase III Clinical trial to evaluate Efficacy and Safety of a Fixed Dose Combination of Thiocolchicoside 16mg SR + Aceclofenac 200mg SR Capsule OD compared with FDC of Thiocolchicoside 8mg + Aceclofenac 100mg Tablet BID for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain associated with muscular spasm. |
|
Scientific Title of Study
|
A Comparative, Randomized Parallel group, Multicentric Prospective Phase III Clinical trial to evaluate Efficacy and Safety of a Fixed Dose Combination of Thiocolchicoside 16mg SR + Aceclofenac 200mg SR Capsule OD compared with FDC of Thiocolchicoside 8mg + Aceclofenac 100mg Tablet BID for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain associated with muscular spasm. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/INV/CT-III/9134/15/03/10 |
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 |
Gautam Saranath |
| Designation |
|
| Affiliation |
|
| Address |
General Manager,Inventia Healthcare Pvt Ltd.
A/505, Veera Industrial Estate, Off Infinity Mall, Andheri Link Road
Mumbai
MAHARASHTRA
400053
India |
| Phone |
+91-9987547061 |
| Fax |
|
| Email |
gautam.saranath@inventiahealthcare.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Pvt. Ltd. A/505, Veera Industrial Estate, Off Infinity Mall, Andheri Link Road, Andheri (W), Mumbai - 400 053. |
|
|
Primary Sponsor
|
| Name |
Inventia Health Care Pvt. Ltd. |
| Address |
|
| Type of Sponsor |
|
|
|
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 HEALTHCARE CLINIC,DA/3-A,MAIN SHAKARPUR MARKET,OPP.NATHU SEETS,-110092
New Delhi
DELHI |
09654807949
drdeepakbhambe@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 From Acute Non Specific Low Back Pain associated with muscular spasm., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Thiocolchicoside 16mg SR + Aceclofenac 200mg SR |
Once a day for 7 Days |
| Comparator Agent |
Thiocolchicoside 8mg + Aceclofenac 100mg |
Twice a day for 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age Eligible for study: 20 years to 75 years
Gender Eligible for study: both
Accepts Healthy Volunteers: No
Non specific low Back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS)
Low Back pain of diagnosis category 1 (low Back pain radiating no farther than the intergluteal fold) or 2 (low Back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain.
Willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Backache due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders.
Backache 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 more than 1.5 mg/dl.
Clinically significant hepatic dysfunction defined by:
Total Bilirubin more than 2 mg/dl.
SGOT (AST) more than 1.5 IU/L.
SGPT (ALT) more than 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. |
|
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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 reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groups. |
Baseline and completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average reduction pain within the last 24 hours assessed using VAS by Investigator and Subject at day 7 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) |
16/12/2010 |
| 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
|
|
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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
|
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) and laboratory investigations LFT and RFT and evaluation of pain on VAS. Female subjects 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 efficacy and ADR evaluation will be done and medication for another 3 days dispensed. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. The reduction in intensity of pain
would be assessed by VAS and the safety evaluation would be done by analyzing the lab parameters (LFT and RFT). Subjects are allowed to visit to investigator at any time point during the study.
|