| CTRI Number |
CTRI/2018/11/016371 [Registered on: 16/11/2018] Trial Registered Prospectively |
| Last Modified On: |
15/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of two drugs, Fixed Dose Combination of Etoricoxib and Thiocolchicoside and Thiocolchicoside Alone in Patients with Painful Muscle Spasm such as torticollis, lumbago, backache. |
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Scientific Title of Study
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A Comparative Study of the Efficacy and Tolerability of Fixed Dose Combination of Etoricoxib and Thiocolchicoside and Thiocolchicoside Alone in Patients with Painful Muscle Spasm |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA S |
| Designation |
Assistant Professor in Department of Pharmacology |
| Affiliation |
KIMS, Bangalore |
| Address |
#497,Elegant embassy,TF-3,17th cross,Ideal Homes,Rajarajeshwarinagar,Bangalore-560098
Bangalore
KARNATAKA
560098
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYANKA S |
| Designation |
Assistant Professor in Department of Pharmacology |
| Affiliation |
KIMS, Bangalore |
| Address |
#497,Elegant embassy,TF-3,17th cross,Ideal Homes,Rajarajeshwarinagar,Bangalore-560098
Bangalore
KARNATAKA
560098
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA S |
| Designation |
Assistant Professor in Department of Pharmacology |
| Affiliation |
KIMS, Bangalore |
| Address |
#497,Elegant embassy,TF-3,17th cross,Ideal Homes,Rajarajeshwarinagar,Bangalore-560098
Bangalore
KARNATAKA
560098
India |
| Phone |
9844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
PRIYANKA S |
| Address |
KIMS,
V.V.Puram,
K R road, Bangalore-560004 |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRIYANKA S |
KIMS, Bangalore-560070 |
Orthopaedic department,
OPD Block,
Room no: 1
Bangalore
KARNATAKA |
9844093100
drpriyanka110@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kempegowda Institute of Medical Sciences, Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, , |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
AIMS AND OBJECTIVES OF THE STUDY:
1. To compare the efficacy of the fixed dose combination of Etoricoxib (60mg)and Thiocolchicoside(4mg) versus Thiocolchicoside(4mg) alone
2. To compare the tolerability of the prescribed medications
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METHODOLOGY
• It is a prospective randomized open-labeled comparative study conducted in the Orthopedics OPD at KIMS
• The study protocol was approved by the institutional review board.Patients attending the outpatient department will be screened and assessed according to the specified inclusion and exclusion criteria.A total of 100 eligible patients of both sexes having painful muscle spasm and willing to take medications as directed and come for the follow -up will be recruited under the study.
• The written informed consent will be obtained from all the study subjects.
• Demographic data and relevant medical history will be obtained from all patients prior to initiation of therapy.
• Patients with age group 18 - 65yrs of either sex with painful muscle spasms will be randomised (1:1 ratio) to receive oral medications of either FDC of Etoricoxib(60mg) with thiocolchicoside(4mg) b.i.d or thiocolchicoside (4mg) alone b.i.d for 7 days.
• Patients will be evaluated for the intensity of pain at rest and on movement on day 0 (visit 1, baseline), day 3 (visit 2) and day 7 (visit 3) by means of a 10 cm visual analogue scale (VAS) as reported by a patient between 0 (no pain) and 10 (unbearable pain).
• Patients Global assessment in response to treatment (PGART) is measured at the end of the study on a scale of 0 to 4. (0-Poor, 1-Fair, 2-Good, 3-Very Good, 4- Excellent)
• The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VAS and secondary efficacy end point by patients global assessment in response to treatment (PGART)
• The tolerability of the prescribed medication will be assessed by the subjective and the objective criteria and adverse effects if any will be recorded.
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| Comparator Agent |
Thiocolchicoside- 4mg |
It is a prospective randomized open-labeled comparative study conducted in the Orthopedics OPD at KIMS • The study protocol was approved by the institutional review board.Patients attending the outpatient department will be screened and assessed according to the specified inclusion and exclusion criteria.A total of 100 eligible patients of both sexes having painful muscle spasm and willing to take medications as directed and come for the follow -up will be recruited under the study. • The written informed consent will be obtained from all the study subjects. • Demographic data and relevant medical history will be obtained from all patients prior to initiation of therapy. • Patients with age group 18 - 65yrs of either sex with painful muscle spasms will be randomised (1:1 ratio) to receive oral medications of either FDC of Etoricoxib(60mg) with thiocolchicoside(4mg) b.i.d or thiocolchicoside (4mg) alone b.i.d for 7 days. • Patients will be evaluated for the intensity of pain at rest and on movement on day 0 (visit 1, baseline), day 3 (visit 2) and day 7 (visit 3) by means of a 10 cm visual analogue scale (VAS) as reported by a patient between 0 (no pain) and 10 (unbearable pain). • Patients Global assessment in response to treatment (PGART) is measured at the end of the study on a scale of 0 to 4. (0-Poor, 1-Fair, 2-Good, 3-Very Good, 4- Excellent) • The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VAS and secondary efficacy end point by patients global assessment in response to treatment (PGART) • The tolerability of the prescribed medication will be assessed by the subjective and the objective criteria and adverse effects if any will be recorded |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between 18-65yrs of age of either gender with painful muscle spasms attending Orthopaedic OPD.
2. Willingness to give written informed consent and available for regular follow up and examination.
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| ExclusionCriteria |
| Details |
1. Patients with history of liver and kidney damage, cardiovascular disease, acid peptic diseases
2. Pregnant and lactating mothers
3. Patients allergic to NSAIDS and skeletal muscle relaxants or prior history of asthma or hypersensitivity potentially requiring concomitant treatment
4. Patients treated with NSAIDS or skeletal muscle relaxants 1 week prior to study
5. Patients with severe concurrent systemic diseases including bleeding diathesis, on anticoagulant therapy.
6. Patients with malignancy, osteoporosis or previous history of lumbar spine surgery
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Alternation |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| • The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VAS |
VAS will be assessed at baseline, 3rd day and 7th day visit to the OPD |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| secondary efficacy end point by patients global assessment in response to treatment (PGART) |
• Patients Global assessment in response to treatment-PGART, is measured at the end of the study on a scale of 0 to 4.
0-Poor, 1-Fair, 2-Good, 3-Very Good, 4- Excellent. |
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Post Marketing Surveillance |
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Date of First Enrollment (India)
|
19/11/2018 |
| 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 |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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References
1. Ram Prabhoo, Swapnil Keny.A Phase IV Observational Multi-centre, Open-label Study on Efficacy and Safety of Tolperisone 150 mg in Patients with Painful Muscle Spasm Associated with Degenerative or Inflammatory Diseases of the Musculoskeletal System.JAPI. Jan 2011;Vol 59:33-37.
2. H.G. Pratzel., R.-G. Alken and S. Ramm. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial. Pain. 67 (1996) 417-425.
3. KD Tripathi. Essentials of Medical Pharmacology. 8th ed.New Delhi: Jaypee Brothers Medical Publishers; 2019.p.373-385.
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Muscle Spasms are characterized by a high prevalence in the general population. Muscle spasm usually accompanies degenerative or inflammatory diseases of the musculoskeletal system and is defined as a sustained involuntary contraction which is usually painful and cannot be relieved completely by voluntary effort. Painful muscle spasms, such as torticollis, lumbago, backache, neuralgias are treated with short term use of centrally acting muscle relaxants combined with analgesics, but efficacy and tolerability is not impressive. Thiocolchicoside is a centrally acting muscle relaxant having unique additional analgesic action. Its sedative property is also negligible and has less adverse effects compared to the others in its group. Etoricoxib is a newer selective COX-2 inhibitor, with gastroprotection being its advantage over other traditional NSAIDS. Though widely used for the above indications, there appears to be no published clinical study comparing the efficacy and tolerability with the intended study drugs, hence the present study is taken up to generate valid and useful data. |