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
|
|
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
|
|
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. |