| CTRI Number |
CTRI/2022/07/043690 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg)
and Thiocolchicoside (4mg) in patients with Low Back Pain. |
|
Scientific Title of Study
|
A Prospective, Randomized, Parallel Group, Open Label, Multi-centric, Active Controlled Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg)
and Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) and Diclofenac(50mg) and Paracetamol(325mg) in Low Back Pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/BRT/21-002 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajat Singhal |
| Designation |
Assistant General Manager (AGM) Medical Affairs |
| Affiliation |
Mankind Pharma |
| Address |
Mankind Pharma Ltd., 208, Okhla Industrial Estate Phase III,
New Delhi
DELHI
110020
India
New Delhi
DELHI
110020
India |
| Phone |
91-11-47476605 |
| Fax |
|
| Email |
drrajatsingal@mankindpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajat Singhal |
| Designation |
Assistant General Manager (AGM) Medical Affairs |
| Affiliation |
Mankind Pharma |
| Address |
Mankind Pharma Ltd., 208, Okhla Industrial Estate Phase III,
New Delhi
DELHI
110020
India
New Delhi
DELHI
110020
India |
| Phone |
91-11-47476605 |
| Fax |
|
| Email |
drrajatsingal@mankindpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat Singhal |
| Designation |
Assistant General Manager (AGM) Medical Affairs |
| Affiliation |
Mankind Pharma |
| Address |
Mankind Pharma Ltd., 208, Okhla Industrial Estate Phase III,
New Delhi
DELHI
110020
India
New Delhi
DELHI
110020
India |
| Phone |
91-11-47476605 |
| Fax |
|
| Email |
drrajatsingal@mankindpharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MANKIND PHARMA LTD |
| Address |
208, Okhla Industrial Estate Phase III, New Delhi, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arnab Karmakar |
IPGMER and SSKM Hospital |
IPGMER and SSKM Hospital
SSKM Hospital Road,
Bhowanipore, Kolkata, West
Bengal 700020
Kolkata
WEST BENGAL |
9830401377
arnab.doctor@gmail.com |
| Dr Sumit Arora |
Maulana Azad Medical College |
Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi11002
New Delhi
DELHI |
9868329389
sumitaroraortho@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAMC |
Approved |
| IPGMEandR Resaerch Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorzoxazone(500mg) and Diclofenac(50mg) and Paracetamol(325mg) |
To be
administered orally, once daily in the morning for a period of 4 weeks |
| Intervention |
Etoricoxib(60mg) and Thiocolchicoside (4mg) |
To be administered orally, once daily
in the morning for a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex in the age range of 18-70 years (both age inclusive) with a history of LBP
and muscle spasm of ≤14 days, with a Wong Bakers Faces Pain scale score >4
2. Willing to give written informed consent and comply with study procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects with back pain due to fractures, malignancy, infection, abnormal metabolism,
osteoarthritis of hip or any other disease,
2. Back pain originating or referred from other organs,
3. Subjects with a history of peptic ulceration or gastrointestinal bleeding or severe dyspepsia,
MC/BRT/21-002
Version: 1.0 dated 03 Feb 2022 Confidential Page 21 of 40
4. Subjects with known allergy to NSAIDs and skeletal muscle relaxants or any component of
the study product
5. Subjects suffering from asthma or other allergic disorders,
6. Subjects with severe comorbid systemic disease including bleedings diathesis, currently on
anticoagulation therapy, hepatic or renal impairment, clinically significant cardiac disease,
neurological disease, or psychiatric disorder
7. Pregnant or lactating women
8. History or evidence of spinal disease (eg, ankylosing spondylitis, rheumatoid arthritis, tumor,
and Paget disease). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in Wong Bakers Face Pain Scale from baseline to week 4 and compared
between the two arms.
2. Mean change in 24 item Oswestry disability index (ODI) scores from baseline to week
4 and compared between the two arms.
|
Baseline to week 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in Wong Bakers Face Pain Scale from baseline to week 2 and compared
between the two arms.
2. Mean change in Oswestry disability index (ODI) scores from baseline to week 2 and
compared between the two arms.
|
Baseline (D0) to week 2 (D14) |
|
|
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 4 |
|
Date of First Enrollment (India)
|
06/07/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The findings of this study may be published in a scientific journal or presented at a scientific meeting with prior permission from the sponsor and the CRO. Sponsor and the CRO reserve the right to review all manuscripts prior to submission for publication or any paper before it is presented. In accordance with standard editorial and ethical practice, the sponsor and the CRO will generally support publication of multicentric trials only in their entirety and not as individual center data. Authorship will be determined by mutual agreement between the sponsor in conjunction with the CRO and the Principal investigator(s). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a Prospective, Randomized, Parallel Group, Open Label, Multi-centric, Active Controlled Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg) +Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) +Diclofenac(50mg) +Paracetamol(325mg) in Low Back Pain. The Primary objective is to evaluate the efficacy of fixed dose combination of Etoricoxib(60mg) +Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) +Diclofenac(50mg) +Paracetamol(325mg) in low back pain post 4 weeks of treatment.
Subjects will be recruited from out-patient departments of study sites. On the randomization visit of Day 0 a written informed consent will be obtained from subjects fulfilling the inclusion/exclusion criteria described in the study protocol. In cases of subjects who have taken NSAIDs or muscle relaxants during the last 3 days a washout period (minimum 2 days for all medications that have an elimination half-life of less than 10 hours or at least 5 times the elimination half-life for medications with longer half-lives1 ). An initial or baseline pain assessment (the day of randomization prior to dosing) will be recorded. Subjects will undergo a physical examination. Subjects will be instructed to fill the Wong Bakers Face Pain Scale and Oswestry disability index (ODI) Subjects will be randomized to one of the two arms as per predefined randomization list. Subject diary will be provided to all enrolled subjects. Baseline laboratory investigations (Complete Hemogram, Liver function and renal function test) will be performed. Subjects will be contacted telephonically at Day 14 and enquired about drug compliance, relief of low back pain and occurrence of any adverse event. At end of study visit subjects will be evaluated physically at site. A complete physical examination will be carried out (Finger to floor distance/ Lasegue’s manuevre). Subjects will be guided to fill the Wong Bakers Face Pain Scale and Oswestry disability index (ODI) for study end assessment. Subject diary will be reviewed. IP compliance will be checked and adverse events experienced would be evaluated. End of study laboratory investigations will be carried out. |