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CTRI Number  CTRI/2023/08/056416 [Registered on: 11/08/2023] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   An Investigator initiated study comparing individual use of Etorocoxib (to reduce pain and swelling) and Thiocolchicoside (a muscle relaxant) against combined use of Etoroxocib and Thiocolchicoside in patients with pain in different regions of the spine along with muscle rigidity and spams. 
Scientific Title of Study   An open-label, randomized, three arm, multicenter, parallel group clinical study of the efficacy and safety of concomitant daily use of Etoricoxib tablets with Thiocolchicoside capsules versus monotherapy with Etoricoxib tablets and Thiocolchicoside capsules in patients with pain syndrome in different regions of the spine, accompanied by muscle tension and spasm 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IGS-CP-003 Version 1.0 dated 11 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrirang Limaye 
Designation  Director and Consultant Orthopedic 
Affiliation  Deoyani Multispeciality Hospital 
Address  OPD number 1, Ground Floor, Deoyani Multispeciality Hospital, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune

Pune
MAHARASHTRA
411038
India 
Phone  9850811722  
Fax    
Email  drshriranglimaye01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shrirang Limaye 
Designation  Director and Consultant Orthopedic 
Affiliation  Deoyani Multispeciality Hospital 
Address  OPD number 1, Ground Floor, Deoyani Multispeciality Hospital, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune


MAHARASHTRA
411038
India 
Phone  9850811722  
Fax    
Email  drshriranglimaye01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrirang Limaye 
Designation  Director and Consultant Orthopedic 
Affiliation  Deoyani Multispeciality Hospital 
Address  OPD number 1, Ground Floor, Deoyani Multispeciality Hospital, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune


MAHARASHTRA
411038
India 
Phone  9850811722  
Fax    
Email  drshriranglimaye01@gmail.com  
 
Source of Monetary or Material Support  
Deoyani Multispeciality Hospital, Plot Number 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune 411038, MAHARASHTRA 
 
Primary Sponsor  
Name  Dr Shrirang Limaye 
Address  OPD number 1, Ground Floor, Deoyani Multispeciality Hospital, Plot No, 121, Lane Number 4, Dahanukar Colony, Kothrud, Pune 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
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 Shrirang Limaye  Deoyani Multispeciality Hospital  OPD number 1, Ground Floor, Plot Number 121, Lane Number 4, Dahanukar Colony, Kothrud 411038
Pune
MAHARASHTRA 
9850811722

drshriranglimaye01@gmail.com 
Dr Swaroop Solunke  Medipoint Hospitals Pvt Ltd  Room no. 1, Ground floor, Clinic Building, 241/1 New DP Road, Aundh 411007
Pune
MAHARASHTRA 
9921101070

drswaroopsolunke.medipoint@gmail.com 
Dr Abhishek Zanwar  Noble Hospital PVT LTD  Room no. 3, 1st floor, Corporate Department, 153A, Magarpatta City Road, Hadapsar 411013
Pune
MAHARASHTRA 
9699507339

abhishek.zanwar@gmail.com 
Dr Pravin Waghmare  Pawana Hospital  OPD Room Number 4 Ground Floor Gat Number 176 Urse Parandwadi Road Somatne Phata Taluka Maval Pune 410506
Pune
MAHARASHTRA 
9172575443

pravinw57@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee Deoyani Multispeciality Hospital  Approved 
Lifepoint Research - Ethics Committee  Approved 
Noble Hospital Institutional Ethics Committee  Submittted/Under Review 
Penta-Med Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain, (2) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etoricoxib tablets with Thiocolchicoside capsules versus   Combination of Etoricoxib and Thiocolchicoside may maximize pain relief by different mechanisms. Etoricoxib provide pain relief by inhibiting cyclooxygenase enzyme and thus decreasing PGE2 synthesis, while Thiocolchicoside is a muscle relaxant for the treatment of acute muscle spasms with additional anti-inflammatory and analgesic properties. The total intervention period is 7 days 
Comparator Agent  Monotherapy with Etoricoxib tablets and monotherapy with Thiocolchicoside capsules  Monotherapy of Etoricoxib 60 mg tablets OD (marketed in India) and Thiocolchicoside capsules, 4 mg BID. The total intervention period is 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Availability of a signed informed consent for study participation, commitment and ability to follow all the Protocol requirements.
2.Patients of both genders aged 18 to 65 years inclusive, with an established diagnosis of
• musculoskeletal (nonspecific) low back pain (LBP) and/or
• musculoskeletal (nonspecific) neck pain (spondylogenic cervicalgia)
3.Compliance with the following diagnostic criteria: • pain, muscle tension, or stiffness that is localized in the neck or between the twelfth pair of ribs and the gluteal sulcus; • pain usually has an aching character of varying intensity, increases with movement in the neck (tilting the head to the side [upper trapezius muscle], moving the arms to the sides [muscle lifting the scapula],bending the head forward, trying to touch the chin to the chest [muscle that straightens the spine])or in the lumbar spine, certain postures, walking and weakens at rest; • absence of symptoms of tension of the nerve roots like tingling, numbness, muscle weakness or increased sensitivity(Lasegue, Wasserman, Matskevich symptoms)
4.The disease course meets the following criteria: • a single episode of pain syndrome lasting at least 24 hours but not more than 3 weeks prior to enrollment in this study, or • a recurrent episode of pain lasting at least 24 hours, but not more than 3 weeks prior to enrollment in this study, provided that the duration of completely asymptomatic periods between relapses is less than 6 months.
5.The severity of pain in the neck or lower back after the most painful movement, as assessed by the patient at screening and before randomization using VAS (0-100 mm), is ≥ 40 mm.
6.Clinical signs (by physical examination and palpation of muscles) of spasticity in the neck or lower back.
7.Pain in the lower back is causing disability(Roland-Morris Disability Questionnaire score ˃ 5 at screening and before randomization), AND/OR Pain in the neck causes disability (Neck Disability Index score ˃ 15 at screening and before randomization). 
 
ExclusionCriteria 
Details  1.Hypersensitivity to NSAIDs, centrally acting muscle relaxants, paracetamol or any other components of the compared drugs.
2.History of Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, rhinitis, angioneurotic oedema, urticaria, or allergic type reactions and respiratory disease induced by NSAIDs.
3.The use of NSAIDs in any dosage form (including oral acetylsalicylic acid as prophylaxis of cardiovascular disorders, at a dose of 75-100 mg/day), non-narcotic and narcotic analgesics in any dosage form within 24 hours prior to enrolling in this study.
4.The use of oral corticosteroids, or in the form of intramuscular injection within 30 days prior to enrollment in this study.
5.The use of corticosteroids in the form of caudal epidural injections (blockade with local anesthetics and corticosteroids) within 3 months prior to enrollment in this study.
6.Spinal or epidural anesthesia and/or lumbar puncture within 3 months prior to enrollment in this study.
7.Use of non-drug therapies prohibited by this protocol within 24 hours prior to enrollment in this study.
8.The need to prescribe to the patient concomitant drug and non-drug therapy prohibited by this protocol.
9.Probable specific etiology of pain in the lower back, identified by history: • recent back injury; • malignant neoplasm, even in the case of the tumor eradication; • current infectious or systemic inflammatory disease; • long-term use of corticosteroids; • history of immunodepression, tuberculosis, HIV infection, alcohol and/or drug addiction; • unexplained weight loss, fever.
10.Probable specific etiology of pain in the lower back, identified by the nature and localization of pain: • pain that progresses over time that is not relieved by rest ("non-mechanical" pain) radiation of pain to the chest, perineum, rectum, abdomen, or vagina; • association of pain with bowel movements and urination.
11.Probable specific etiology of pain in the lower back (including but not limited to the following), identified by CT /MRI as per investigator discretion: • malignant neoplasm; • infection of the vertebrae or discs; • cauda equina syndrome; • compression fracture of the vertebra; • disc herniation and/or lumbar stenosis.
12.Signs of radiculopathy and other neurological diseases (paresis, loss of reflexes, sensory disorders, pelvic disorders, etc.).
13.History of Erosive and ulcerative changes in the gastric and duodenal mucousa, inflammatory bowel disease or active gastrointestinal bleeding.
14.Severe liver dysfunction (serum albumin <25 g/l). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of concomitant use of Etoricoxib tablets 60 mg OD & Thiocolchicoside capsules 4 mg BID versus the mono use of Etoricoxib 60 mg tablets OD (marketed in India) & Thiocolchicoside capsules 4 mg BID (marketed in India) in patients with pain syndrome in different regions of the spine accompanied by muscle tension and spasm  Day 1 to Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety & tolerability of concomitant use of Etoricoxib tablets 60 mg OD and Thiocolchicoside capsules 4 mg BID versus the mono use of Etoricoxib 60 mg tablets OD (marketed in India) and Thiocolchicoside capsules 4 mg BID (marketed in India) in patients with pain syndrome in different regions of the spine accompanied by muscle tension and spasm  Day 1 to Day 15 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "158"
Final Enrollment numbers achieved (India)="158" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   18/08/2023 
Date of Study Completion (India) 29/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective, observational, multicenter, open label study to evaluate and compare the safety and efficacy of 150 adult patients with pain syndrome in different regions of the spine, accompanied by muscle tension and spasm at 4 sites across India. Prior to being enrolled into the study patients must provide written authorization to the investigator to use or disclose personal and/or clinical data and meet the study eligibility criteria. Data that would be collected are Anthropometry, patient survey for complaints, Demographic and social habits data collection, medical history collection, information collection and assessment of earlier and concomitant therapies, Physical examination, questionnaires and Scales. 
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