| CTRI Number |
CTRI/2010/091/000127 [Registered on: 01/09/2010] |
| Last Modified On: |
21/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical study to evaluate the efficacy and safety of FDC of Tolperisone and Paracetamol in patients suffering from acute muscle spasms |
Scientific Title of Study
Modification(s)
|
A prospective, controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Fixed Dose Combination of Tolperisone 150 mg and Paracetamol 500 mg in patients suffering from acute muscle spasms |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TOL PCM/TML/07/09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Harshad Argekar Dr Ramesh Sen Dr Anil Baburao Dhule |
| Designation |
|
| Affiliation |
|
| Address |
Criticare Hospital & Research Centre,Plot No. 38/39, Main Gulmohar Road, J.V.P.D. Scheme, Andheri (West); Additional Professor, Dept. of orthopedics, PGIMER, Chandigarh;
Lecturer- Dept. of Orthopaedic, Govt. Medical College, Aurangabad
Mumbai
MAHARASHTRA
400 049
India |
| Phone |
9820654780 |
| Fax |
|
| Email |
argekar@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harshad Argekar Dr Ramesh Sen Dr Anil Baburao Dhule |
| Designation |
|
| Affiliation |
|
| Address |
Criticare Hospital & Research Centre,Plot No. 38/39, Main Gulmohar Road, J.V.P.D. Scheme, Andheri (West); Additional Professor, Dept. of orthopedics, PGIMER, Chandigarh;
Lecturer- Dept. of Orthopaedic, Govt. Medical College, Aurangabad
Mumbai
MAHARASHTRA
400 049
India |
| Phone |
9820654780 |
| Fax |
|
| Email |
senramesh@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sumedh M Gaikwad |
| Designation |
|
| Affiliation |
|
| Address |
Themis Medicare Limited,
11/12, Udyog Nagar, S. V. Road, Goregaon (West),
Mumbai
MAHARASHTRA
400 104
India |
| Phone |
02267603320 |
| Fax |
02228785393 |
| Email |
sumedh.gaikwad@themismedicare.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Themis Medicare Limited |
| Address |
11/12, Udyog Nagar, S. V. Road, Goregaon (West), Mumbai - 400 104. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshad Argekar |
Criticare Hospital & Research Centre, |
Plot No. 38/39, Main Gulmohar Road,,J.V.P.D. Scheme, Andheri (West)-400 049
Mumbai
MAHARASHTRA |
9820654780
argekar@gmail.com |
| Dr. Anil Baburao Dhule |
Government of Medical College |
Lecturer - Dept of Orthopaedic,,GMC, Aurangabad-
Aurangabad
BIHAR |
09823078631
|
| Dr. Ramesh Sen |
Post Graduate Institute of Medical Education and Research |
Additional Professor, Dept. of Orthopaedics,,Chandigarh-
Chandigarh
CHANDIGARH |
09815409652
senramesh@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| C.A.R.E. Independent Ethics Committee, Mumbai |
Approved |
| Institute Ethics Committee, PGIMER |
Approved |
| Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Muscle Spasms , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
FDC OF TOLPERISONE + PARACETAMOL TABLETS |
TOLPERISONE 150 MG + PARACETAMOL 500 MG (FDC), WITH PLACEBO TABLET THRICE DAILY FOR 21 DAYS |
| Comparator Agent |
TABLET TIZANIDINE AND TABLET PARACETAMOL |
TIZANIDINE 2 MG AND PARACETAMOL 500 MG AS SEPERATE TABLETS GIVEN THRICE DAILY FOR 21 DAYS |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group between 18 to 70 years.
2. Patients presenting with moderate to severe painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
3. Subjects who provide a written informed consent to abide by the study requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients with acute muscle spasms who need parenteral therapy / surgery / hospital admission for management.
2. Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDS & OPIOIDS) within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period.
3. Patients suffering from organic neurological disorders (Upper motor neuron disorders, cerebral palsy, pyramid tract injury, multiple sclerosis, cerebrovascular events, myelopathy, encephalomyelitis, etc), peripheral vascular diseases (arteriosclerosis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's disease and other encephalopathies accompanied by dystonia.
4. Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom.
5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
7. Pregnant and lactating females.
8. Simultaneous participation in another clinical study. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Pain intensity, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom free |
0, 4 days, 7 days, 14 days, 21 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Digit / alphabet cancellation test, Reaction time :auditory and visual using the reaction time apparatus, Flicker fusion frequency using the flicker fusion apparatus, Measurement of hand grip strength, ADR recording, blood investigations |
0, 21 days. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/02/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1.Szobor,A.(1991)Mydocalm:30 Years in Therapy. Gyógyszereink41:110-117.RGD 42475
2.Meilinger,M.,Zalaváry I. 2002)Tolperisone in acute low back pain,a randomized, parallel-group,placebo-controlled,double-blind clinical study.(TOLERATE) Clinical Study Report RGD 57710
3.Wilbraham,D./Guy’s Drug Research Unit/(2003)A randomised,double-blind dose-escalating study in healthy male volunteers to examine the safety,tolerability and pharmacokinetics of oral tolperisone hydrochloride in single and repeat doses higher than previously administered to humans. ClinicalTrialReport.RGD:59478
4. A)Pratzel, H.G., Alken, R.-G., Ramm, S. (1996) 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: 417-425. RGD 50119 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A prospective, controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Fixed Dose Combination of Tolperisone 150 mg and Paracetamol 500 mg in patients suffering from acute muscle spasms. (200 PATIENTS ENROLLED) |