| CTRI Number |
CTRI/2011/11/002116 [Registered on: 11/11/2011] Trial Registered Prospectively |
| Last Modified On: |
23/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A multiple centre study to check the efficacy and safety of Topical formulation of Diclofenac plus Thiocolchicoside in comparison with Diclofenac gel in acute low back pain. |
|
Scientific Title of Study
|
A randomised, two arm, openlabel, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical fixed dose combination of a muscle relaxant Thiocolchicoside and a non steroidal anti-inflammatory drug, Diclofenac in comparison with Diclofenac Topical gel ( 1.16% w/w) in acute non-specific low back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/01/05 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Maroo |
| Designation |
GM - Medical services |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1
Opp Rajvansh Tower
Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
medicalservices@troikaapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Maroo |
| Designation |
GM - Medical services |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1
Opp Rajvansh Tower
Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
medicalservices@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Maroo |
| Designation |
GM - Medical services |
| Affiliation |
Troikaa Pharmaceuticals Ltd. |
| Address |
Troikaa Pharmaceuticals Ltd.
Commerce House-1
Opp Rajvansh Tower
Off. Judges Bunglows
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
medicalservices@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Ltd.
Commerce House 1
Opp Rajvansh Tower
Off. Judges Bunglow
Ahmedabad
380054 |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Commerce House 1
Opp Rajvansh Tower
Off Judges Bunglow
Ahmedabad
380054 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajiv Jain |
Department of Orthopaedics |
OPD Room No 3, Basement,
Surya Hospital
Krishnanagar,
New Delhi 110051
East
DELHI |
09810144912
docrajivj@gmail.com |
| Dr Rakesh Singh |
Department of Orthopaedics |
Galaxy Medical Centre
1D- A Birdopur
Mahmoorganj
Sigra,
Varanasi
UTTAR PRADESH |
09415085658
singhrksortho@rediffmail.com |
| Dr Binod Kumar |
Department of Orthopaedics, |
Sudama Fracture Clinic
Room No 15, 3rd Floor
Ravindrapuri
Durgakund
Varanasi
UTTAR PRADESH |
09235724466
binodbinod2007@rediffmail.com |
| Dr Malhar Dave |
Department of Orthopaedics, |
Abhishek Hospital,
Shivalik Complex
Near Sitaram Complex
Shubhanpura Main Road
390023
Vadodara
GUJARAT |
09824051009
malhard3@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya. |
Approved |
| Independent Ethics Committee Aditya |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In acute nonspecific Low back painful condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Gel |
4 times a day for 7 days |
| Intervention |
Topical solution of Diclofenac plus Thiocolchicoside |
4 times a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male of Female patients aged 18-60 years
2. Non specific low back pain with an acute episode of recent onset(less than 48 hours) defined by average pain within the last 24 hours equal or more than 5 on the Visual Analogue Scale (VAS)
3. Low back pain of diagnostic 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
4. Patients who are willing to take medications as directed, to come for follow ups, to give written consent and comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination)such as neoplasm, infection or inflammatory disorders.
2. Low back pain of diagnostic 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.
3. History of Inflammatory arthritis of Large Joints, or any structural deformity.
4. History of seizure disorder, or any recent history of violent trauma, psychiatric or mental diseases or any widespread neurological symptoms.
5. History of malignant tumor.
6. Patient who have received other therapy [NSAIDs( including aspirin), muscle relaxant or opioid analgesics, physiotherapy, physical manipulations, invasive intervention, accupuncture therapy] within last 48 hours.
7. History of Immunosuppression, HIV or use of immunosuppressive drugs.
8. Inclusion in another study in past 6 months or previous inclusion in this study.
9. History of alcohol, drug or narcotics abuse.
10. Constant progressive, non mechanical pain(no relief with bed rest)
11. Thoracic pain
12. Patient systemically unwell or having fever, or unexplained weight loss.
13. Clinically significant renal dysfunction/ hepatic dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief with study medication |
On Day 3 (telephonic follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Analgesic scores.
2.Severity of Pain,Local tenderness, Degree of functional impairement.
3. Total Analgesia using Rolland Morris Disability Questionnaire
4. Physicians & Patients Global Assessment |
1. Day 3 (Telephonic follow up) and day 7 (End of the study treatment).
2. Day 7 (End of the study visit).
3. Baseline and Day 7 (End of the study Visit).
4. Day 7 (End of the Study Visit) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/11/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was a randomised, two arm, open label, active controlled, multicentric clinical study to evaluate the safety and efficacy of a topical fixed dose combination of a muscle relaxant thiocolchicoside and a non steroidal anti inflammatory drug , diclofenac in comparison with diclofenac topical gel (1.16 w/w) in acute non specific low back pain in total of 150 patients at multiple sites in India. Patients were randomised to receive either diclofenac plus thiocolchicoside topical solution or topical diclofenac gel. The primary outcome was pain relief with study medication, to be assessed on Day 3 . The secondary outcome was pain relief on Day 7, pain relief scores for the entire treatment period, Rolland Moris Disability score along with patients & physicians global assessment on Day 7.
Pain relief on Day 3 and Day 7 of treatment was significantly higher in Diclofenac + Thiocolchicoside group as compared to the Diclofenac gel group. Pain relief score for the entire treatment period and Roland and Morris Disability scoring were significantly higher in the Diclofenac + Thiocolchicoside group as compared to Diclofenac gel group. Both physicians and patient global assessment were favorable towards Diclofenac + Thiocolchicoside group as compared to Diclofenac gel group.
Thus it can be concluded that Topical solution of Diclofenac + thiocolchicoside is more effective as compared to Diclofenac Topical gel in the management of acute nonspecific low back pain. No adverse event was reported among both the treatrment groups and both the treatment were found safe.
|