| CTRI Number |
CTRI/2010/091/002939 [Registered on: 19/11/2010] |
| 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 trial to study the effects of two drugs, in fixed dose combination tablet - Aceclofenac and Thiocolchicoside Sustained Release in patients suffering from painful muscle spasms associated with musculoskeletal systems. |
Scientific Title of Study
Modification(s)
|
A prospective, controlled, randomized, open, comparative, parallel, 2 - arm study to evaluate the efficacy and safety of FDC tablet of Aceclofenac 200 mg and Thiocolchicoside 16 mg SR versus FDC tablet of Aceclofenac 100 mg and Thiocolchicoside 8 mg IR in patients suffering from painful muscle spasms associated with musculoskeletal systems. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ACE THI/TML/08/10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Satish Masavkar Dr Anil Baburao Dhule Dr Amit K Bali |
| Designation |
|
| Affiliation |
|
| Address |
Ashirwad Hospital, Rajiv Sadan, Opp. Sion Railway Station, Sion; Dhule Hospital, Aurangabad
Rajawadi Hospital, Ghatkopar
Mumbai
MAHARASHTRA
400 022; 400 077
India |
| Phone |
9869055473 |
| Fax |
|
| Email |
drmsatish@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Satish Masavkar Dr Anil Baburao Dhule Dr Amit K Bali |
| Designation |
|
| Affiliation |
|
| Address |
Ashirwad Hospital, Rajiv Sadan, Opp. Sion Railway Station, Sion; Dhule Hospital, Aurangabad
Rajawadi Hospital, Ghatkopar
Mumbai
MAHARASHTRA
400 022; 400 077
India |
| Phone |
9869055473 |
| Fax |
|
| Email |
drmsatish@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sumedh M Gaikwad |
| Designation |
Director-Medical Services |
| Affiliation |
|
| Address |
C/o Themis Medicare Limited, 11/12, Udyog Nagar,
S. V. Road, Goregaon (West),
Mumbai
MAHARASHTRA
400 104
India |
| Phone |
022-67603320 |
| Fax |
022-67607070 |
| Email |
sumedh.gaikwad@themismedicare.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Themis Medicare Limited, Mumbai |
|
Primary Sponsor
Modification(s)
|
| Name |
Themis Medicare Limited Udyog Nagar S V Road Goregaon West Mumbai |
| 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. Satish Masavkar |
Ashirwad Hospital |
Rajiv Sadan, Opp. Sion Railway Station,,Sion-400 022
Mumbai
MAHARASHTRA |
9869055473
drmsatish@gmail.com |
| Dr Anil Baburao Dhule |
Dhule Hospital |
Dhule Hospital, Aurangabad,-
Aurangabad
BIHAR |
9823078631
dranilbdhule@gmail.com |
| Dr. Amit K. Bali |
Rajawadi Hospital |
Ghatkopar,-400 077
Mumbai
MAHARASHTRA |
9821039909
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
| Seth V.C.Gandhi & M.A. Vora Municipal General Hospital, Rajawadi, Mumbai |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Painful muscle spasms associated with musculoskeletal systems, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
FDC Aceclofenac 200 mg and Thiocolchicoside 16 mg SR Tablet |
1 tablet once daily for maximum of 14 days, if patient is symptom free earlier than 14 days the medication can be stopped |
| Comparator Agent |
FDC of Aceclofenac 100 mg and Thiocolchicoside 8 mg IR Tablet |
Twice daily for maximum period of 14 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 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 painful muscle spasms associated with musculoskeletal systems, 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 (number of episodes patient needed T. Paracetamol)Time needed for the patient to be symptom free |
0, 4 days, 7 days, 14 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, 14 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/11/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
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, open, comparative, parallel, 2-arm study to evaluate the efficacy and safety of FDC tablet of Aceclofenac 200 mg and Thiocolchicoside 16 mg SR verus FDC tablet of Aceclofenac 100 mg and Thiocolchicoside 8 mg IR in patients suffering from painful muscle spasms associated with musculoskeletal systems. |