| CTRI Number |
CTRI/2010/091/006069 [Registered on: 29/12/2010] |
| Last Modified On: |
14/11/2013 |
| Post Graduate Thesis |
|
| 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 trial to study the effects of two drugs, Tolperisone and Diclofenac in patients suffering from acute muscle spasms |
Scientific Title of Study
Modification(s)
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A prospective, controlled, randomized, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet containing Tolperisone (150mg) and Diclofenac (50mg) in patients suffering from acute muscle spasms |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TOL DIC/TML/07/09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vijay G Ghoni |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
Adarsh Nagar (Jain Health Care Clinic), Worli. ; Government Medical College, Aurangabad
Dept of Orthopaedic, PGIMER, Chandigarh
Mumbai
MAHARASHTRA
400 025; 431 003;
India |
| Phone |
09815712727 |
| Fax |
|
| Email |
vijaygoni@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sunil Shetty Dr Anil Baburao Dhule Dr Vijay G Ghoni |
| Designation |
Dr. Goni ----- Additional Professor |
| Affiliation |
|
| Address |
Adarsh Nagar (Jain Health Care Clinic), Worli. ; Government Medical College, Aurangabad
Dept of Orthopaedic, PGIMER, Chandigarh
Mumbai
MAHARASHTRA
400 025; 431 003;
India |
| Phone |
09815712727 |
| Fax |
|
| Email |
vijaygoni@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sumedh M Gaikwad |
| Designation |
Director-Medical Services |
| Affiliation |
|
| Address |
Themis Medicare Limited, 11/12, Udyog Nagar, S. V. Road,
Goregaon (West),
Mumbai
MAHARASHTRA
400 103
India |
| Phone |
022-67603320 |
| Fax |
022-28785393 |
| 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. Sunil Shetty |
Adarsh Health Clinic, |
(Jain Health Clinic) ,Adarsh Nagar, Worli,-400 025
Mumbai
MAHARASHTRA |
9821288076
|
| Dr Anil Baburao Dhule |
Government Medical College |
Aurangabad
Aurangabad
MAHARASHTRA |
9823078631
dranilbdhule@gmail.com |
| Dr. Vijay G. Goni |
Post Graduate Institute of Medical Education & Research (PGIMER), |
Sector ? 12,,-160 012
Chandigarh
CHANDIGARH |
09815712727
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
| Institute Ethics Committee, Chandigarh |
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 |
| Comparator Agent |
Diclofenac Sodium 50 mg Tablet |
Thrice daily for maximum period of 21 days |
| Intervention |
FDC of Tolperisone 150 mg + Diclofenac 50 mg Tablet |
Fixed Dose Combination Tablet ----- Thrice daily for maximum period of 21 days |
|
Inclusion Criteria
Modification(s)
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| 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 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) medications within 1 week prior to the study.
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, diabetic angiopathy, thrombangiitis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's diseases 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)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Pain intensity (recorded on VAS), tenderness (graded from 0 to 3), joint mobility (recorded on VAS), Spasm relief (recorded on VAS), 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)
|
28/12/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| 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.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
2.Wilbraham,D./Guy’s Drug Research Unit/(2003)A randomised, double-blind dose-escalating study in healthy male volunteers to examine the safety, tolerab-ility & pharmacokinetics of oral tolperisone hcl in single & repeat doses higher than previously administered to humans. Clinical Trial Report. RGD: 59478
3.A)Pratzel,H.G.(1995)A prospective, randomised, double-blind, placebo controlled trial in parallel groups of patients for the proof of efficacy of Mydocalm for treatment of painful reflex muscle spasm.(Study No 35.5)Final Report. RGD 48325
B)Pratzel,H.G.,Alken,R.-G., Ramm, S.(1996)Efficacy & tolerance of repeated oral doses of tolperisone hcl in treatment of painful reflex muscle spasm: results of a prospective placebo-controll-ed 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)
|
This study is a controlled, randomized, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet containing Tolperisone 150 mg and Diclofenac 50 mg in patients suffering from acute muscle spasms. |