| CTRI Number |
CTRI/2010/091/001178 [Registered on: 12/08/2010] |
| Last Modified On: |
11/09/2013 |
| 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)
|
To determine the efficacy and safety of Extended release Paracetamol 650 mg tablet twice a day versus Conventional Paracetamol 500 mg tablet three times a day in the treatment of Osteoarthritis (OA) of knee. |
Scientific Title of Study
Modification(s)
|
A randomized comparative study evaluating efficacy and tolerability of Extended Release Paracetamol 650 mg tablet twice a day versus Conventional Paracetamol 500 mg tablet three times a day in the treatment of Osteoarthritis (OA) of knee.
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CT/19/02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjay Maroo |
| Designation |
Sr GM |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
79-26856242 |
| Fax |
|
| Email |
sanjaymaroo@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjay Maroo |
| Designation |
Sr GM |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
79-26856242 |
| Fax |
|
| Email |
sanjaymaroo@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjay Maroo |
| Designation |
Sr GM |
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House- 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
79-26856242 |
| Fax |
|
| Email |
sanjaymaroo@troikaapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Troikaa Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House 1, Opp.Rajvansh Apartment
Satya Marg, Bodakdev
Ahmedabad 380054 |
| 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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishwanath Yaligod |
Department of Orthopaedics, Sapthagiri Institute of Medical Sciences & Research Center |
#15, Chikkasandra, Hesaraghatta Main Road, Bangalore - 560090
Bangalore
KARNATAKA |
09342405896
vvyaligod@rediffmail.com |
| Dr D Gokul Raj |
Department of Orthopedics, Sri Ramchandra Medical College |
Sri Ramchandra Medical College, Sri Ramchandra university
Ramchandra Nagar
Porur
Chennai -600 116
Chennai
TAMIL NADU |
09840150310
orthogokul@gmail.com |
| Dr Sumit Batra |
Department of Orthopedics, VMMC &safdarjang hospital |
Safdarjung Hospital
New Delhi- 110029
New Delhi
DELHI |
09891311278
sumitbatra104@hotmail.com |
| Dr Ateet Sharma |
Satellite orthopaedic Hospital & Research Centre Pvt. ltd |
Department of orthopaedics,
302, Vraj Complex, Opp. Dhananjay Tower,
100 Ft. Road, Near Shyamal Cross Roads,
Ahmadabad
GUJARAT |
91-9824061766
ateetsharma72@rediffmail.com |
| Dr. Apurv Acharya |
Siddhi Vinayak Hospital |
Balvatika Maninagar Road,Kankariya, Maninagar-380008
Ahmadabad
GUJARAT |
+91-9825488253
apurv18275@yahoo.co.in |
| Dr Mallikarjunswamy |
St. John’s Medical College & Hospital, Institutional Ethical Review Board |
St. John’s Medical College & Hospital, Sarjapur Road, Bangalore- 34
Bangalore
KARNATAKA |
09902543909
bms_chandra@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Independant Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Institutional Ethical Review Board , St. John’s Medical College & Hospital |
Approved |
| Institutional Ethics commitee VMMC & Safdarjung Hospital |
Approved |
| Institutional ethics commitee, SRMC, SRU |
Approved |
| Institutional Ethics Committee, SIMS & RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Osteoarthritis (OA) of knee., |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Paracetamol 500 mg tablet |
One tablet three times a day for 6 Weeks. |
| Intervention |
Paracetamol Extended Release Tablet 650 mg |
One Tablet twise daily for 6 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 45 years or older suffering from symptomatic osteoarthritis of knee for at least 3 months
2. Meeting the American College of Rheumatology (ACR) criteria for OA of the knee
3. Patients having moderate pain (VAS score 3 or greater) in disease joint when not taking analgesics
4. Patients having a washout period of Paracetamol or NSAIDs for at least 48 hours (or longer depending on the pharmacokinetic of drug) before starting the study drug. |
|
| ExclusionCriteria |
| Details |
1. Patients having intraarticular injection of any drug within last 4 week
2. Patients with history of chronic alcoholism or patients who regularly consumes alcohol
3. Patients with history of major trauma or surgery in the study joint in previous 6 months
4. Patients with history of acute inflammatory arthritis or pseudogout of the study joint
5. Radiographic evidence suggestive of other type of arthritis, fibromyalgia or collagen vascular disease
6. Patients with clinically unacceptable liver function test
7. Patients requiring hospitalization
8. Patients with compromised hepatic and renal function
9. Pregnant and lactating women
10.Women of child bearing age not practicing or not willing to use contraceptive
11.Patients with history of bronchial asthma, peptic ulceration, bronchitis or any other contraindication to study drug
12. Mentally retarded patients
13. Patients not willing to sign written informed consent
14. Patients with known hypersensitivity to NSAIDs and or related products
15. Patients receiving prescription analgesics, anti-inflammatory agents, myorelaxant drugs, psychotropic agents or any other drug affecting the evaluation of analgesic action
16. Patients who participated in any clinical trial with in 30 days before enrollment into the study
17.Patients, for any reason who are considered to be unsuitable candidates by the investigator. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Severity of pain on Visual Analogue Scale
2. Overall assessment of KOOS score for pain
3.End of study global assessment for overall symptom relief |
1.Baseline and At the end of 2, 4 and 6 week
2.Baseline and At the end of 2, 4 and 6 week
3.At the end of 6 week |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from baseline to final assessment in the KOOS sub-score for parameters other
than pain (symptoms, stiffness, functions daily living, functions sports and recreation
& QOL) |
At the end of 2 week 4 week and 6 week |
| Physician Global Evaluation of treatments |
At the end of study(week 6) |
| Need for Rescue analgesia |
Throughout the study |
| Adverse Events |
Throughout the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
21/08/2010 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Publisted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Osteoarthritis (OA) is a rheumatic disease in which the joint pain and stiffness can lead to significant disability and functional impairment. The knee is the most common site to be affected. Paracetamol is one of the most widely used analgesic for mild to moderate pain states. Extended release formulation of paracetamol has been shown effective and well tolerated in treating moderate to moderately sever chronic OA pain of hip and knee. |