| CTRI Number |
CTRI/2010/091/000059 [Registered on: 01/10/2010] |
| Last Modified On: |
30/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee |
|
Scientific Title of Study
|
Evaluation of efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee: An open, prospective, randomized three arm study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MRCK/FLEX/02/09 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Assistant Manager Clinical Operation |
| Affiliation |
Merck Limited |
| Address |
A -Shivsagar Estate
Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
91-22-66609003 |
| Fax |
91-22-4936046 |
| Email |
khokan.debnath@merck.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Assistant Manager Clinical Operation |
| Affiliation |
|
| Address |
A- Shivsagar Estate
Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
91-22-66609003 |
| Fax |
91-22-4936046 |
| Email |
khokan.debnath@merck.co.in |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Merck Limited |
| Address |
5th floor, A, Shivsagar estate, Dr. Annie Besant Road, Worli 18, Mumbai, Phone- 66609000 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Smega Drugs Research Lab |
Pratik Society, 16-251. K.N. Nagar -1 Vikhroli (E) Mumbai-83 Phone-91-2578566
91-9867757856 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrakant Thorat |
GMC - Aurangabad |
Panchakki Road
Aurangabad 431001
Aurangabad
BIHAR |
91-9820654780
91-0240-2402418
drcrt2007@rediffmail.com |
| Dr Ajay Chandanwale |
J J Hospital |
J J Hospital Grant Medical College Byculla Mumbai 400008
Mumbai
MAHARASHTRA |
91-9420697474
drasc62@rediffmail.com |
| Dr Bikash Medhi |
PGIMER |
PGIMER,Sector 12-160012
Chandigarh
CHANDIGARH |
91-9815409652
drbikashus@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee: Institutional ethics committee, GMC, Mumbai |
Approved |
| Ethics Committee: Institutional ethics committee, PGIMER, Chandigarh Under |
Approved |
| Ethics Committee: Institutional ethics committee- Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Painful osteoarthritis of Knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flexi Joint capsules |
Each capsule contains glucosamine sulphate 500 mg plus Omega 3 Fatty Acids in the form of EPA 90 mg & DHA 60 mg)
Dose: One soft gelatin capsule 3 times in a day orally for 12 weeks
|
| Comparator Agent |
Glucosamine |
Glucosamine sulphate 500 mg
Dose: One tablet 3 times in a day orally for 12 weeks
|
| Comparator Agent |
Maxepa |
Each capsule containing EPA 90 mg & DHA 60 mg. Dose: One capsule 3 times in a day orally for 12 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
- Patients of either sex above 25 years of age
- Clinical diagnosis of primary Osteoarthritis (OA) of the knee (tibiofemoral joint) based on clinical and radiographic criteria. i.e. patients at the time of enrollment in this study having mild to moderate unilateral or bilateral knee pain with or without morning stiffness of <30 minutes duration, and radiographic osteophytes with one or more of the following:
? Marginal lipping
? Narrowing of joint space
? Sharpened articular margin
? sclerosis i.e. damaged thickened or eburnated subchondral bone cysts
- ARA Functional Class I, II, or III
- Clinical symptoms of OA for at least 6 months prior to study entry
- Patient ready to give informed consent.
|
|
| ExclusionCriteria |
| Details |
-Patients having overt joint deformity
-Traumatic joint pain.
-Patients who require surgical intervention
-History of Ischemic Heart Disease
-Pregnant and lactating females
-Those receiving corticosteroid treatment
-Patients with H/O gastritis, peptic ulcer, bleeding ulcers.
-Patients with known hepatic or renal impairment
-Intra-articular injection of corticosteroids, hyaluronic acid or congeners into study joint with 12 months
-Implementation of any other medical therapy for arthritis within 1 week prior to enrollment.
-Patients with known hypersensitivity to any component of study drug.
-Pregnant and lactating females
-Patients with H/O drug/alcoholic abuse
-Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - Improvement in the WOMAC 21 (Western Ontario and McMaster Universities) Score (Sum total of subscale scores for Pain, Stiffness and Function deficit) |
At the end of study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - Reduction of concurrent use of rescue analgesic
- Global Efficacy Assessment evaluated on a 5-point scale of Excellent, Good, Fair, Poor, & Worse
|
At the end of study period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="210"
Sample Size from India="210"
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
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
10/05/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It a trial to evaluate efficacy and tolerability of a fixed dose combination of Glucosamine sulphate and Omega 3 Fatty Acid For treatment of Painful Osteoarthritis of knee. Its an open, prospective, randomized three arm study.The estimated sample size for three arm study is 180 anticipating a dropout rate of 15%, a total of 210 patients would be enrolled (70 in each arm).210 patients would be enrolled (70 in each arm).All medications to be administered by oral route. The study will be conducted at 3 centres all across the country. There are three arms in the study. Study arm is a combination Glucosamine and Omega three fatty acids versus plain Glucosamine versus plain Omega three fatty acids |