| CTRI Number |
CTRI/2009/091/001021 [Registered on: 09/04/2010] |
| Last Modified On: |
27/10/2018 |
| 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, fixed dose combination tablets of Etodolac & Tolperisone hydrochloride and Tolperisone hydrochloride tablets in patients with musculoskeletal disorders associated with painful muscle spasm. |
Scientific Title of Study
Modification(s)
|
An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets containing Etodolac & Tolperisone hydrochloride in comparison with Tolperisone hydrochloride tablets in patients suffering from musculoskeletal disorders associated with painful muscle spasm. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 08-33 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower
Satellite Cross Roads
Ahmedabad
GUJARAT 380015
India |
| 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 = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshu Panchal |
B.J. Medical College and Civil Hospital, Ahmedabad |
Dept. of Orthopaedics,B.J. Medical College and Civil Hospital-380016
Ahmadabad
GUJARAT |
079-22683721
079-22683721
drhimanshupanchal@gmail.com |
| Dr. Arun Vaishy |
Dr. S.N. Medical College, Jodhpur |
Dept. of Orthopaedics,Dr. S.N. Medical College-
Jodhpur
RAJASTHAN |
monavaishy@yahoo.co.in |
| Dr. Rajiv Daveshwar |
Govt. Medical College, & S.S.G. Hospital, Vadodara |
Dept. of Orthopaedics,,Govt. Medical College, & S.S.G Hospital-
Vadodara
GUJARAT |
|
| Dr. Ashok Khandaka |
Mahatma Gandhi National Institute of Medical Sciences. Jaipur |
Dept. of Orthopaedics,Mahatma Gandhi National Institute of Medical Sciences-
Jaipur
RAJASTHAN |
drkhandaka@gmail.com |
| Dr. Yatin Desai |
N. H. L. Municipal Medical College and Sheth V. S. General Hospital. Ahmedabad |
Dept. of Orthopaedics,N. H. L. Municipal Medical College and Sheth V. S. General Hospital-
Ahmadabad
GUJARAT |
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - Dr. S. N. Medical College & Associated Group of Hospitals, Jodhpur |
Approved |
| Institutional Ethics Committee - B.J. Medical College & Civil Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee - Mahatma Gandhi Medical College & Hospital, Jaipur |
Approved |
| Institutional Ethics Committee - Sheth V.S. General Hospital & Sheth Chinai Maternity Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee for Human Research (IECHR) Medical College & S.S.G. Hospital, Vadodara |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Musculoskeletal disorders associated with painful muscle spasm, (1) ICD-10 Condition: M628||Other specified disorders of muscle, (2) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed-dose combination tablets of Etodolac 400 mg & Tolperisone hydrochloride 150 mg |
Thrice in a day for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier |
| Comparator Agent |
Tolperisone hydrochloride 150 mg tablets |
Thrice in a day for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex between the age of 18-60 years.
2.Patients with an established diagnosis of musculoskeletal disorders associated with painful muscle spasm of at least moderate severity at the time of enrolment into the study.
3.Informed consent of the patient/relative/legal representative.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy & Lactation.
2. Patients with hepatic and / or renal insufficiency.
3. Patients with myasthenia gravis.
4. Patients with active peptic ulceration within the last 6 months.
5. Patients suffering from coronary heart disease, uncontrolled hypertension, congestive heart failure or any other significant cardiovascular disorder.
6. Patients suffering from any hemorrhagic diasthesis.
7. Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs.
8. Patients with hypersensitivity to Etodolac, Tolperisone hydrochloride or any other components of the formulations.
9. Patients with any other serious concurrent illness or malignancy.
10. Patients with continuing history of alcohol and / or drug abuse.
11. Participation in another clinical trial in the past 3 months. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline. |
0,3,7,10 & 14 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) The degree of improvement in the individual scores of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.
(2) The investigators? global assessment of efficacy at the end of the study. |
0,3,7,10 & 14 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)
|
06/04/2010 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination tablets of Etodolac 400 mg & Tolperisone hydrochloride 150 mg and Tolperisone hydrochloride 150 mg tablets given thrice a day each for a maximum of 14 days or till complete muscle spasm relief is obtained, whichever is earlier; in 200 patients with musculoskeletal disorders associated with painful muscle spasm that will be conducted in five centers only in India. The primary outcome measures will be the degree of improvement in the composite score of intensity of pain, restriction of mobility and muscle tension at the affected site at each follow-up visit and at the end of therapy as compared to baseline.. |