| CTRI Number |
CTRI/2009/091/000928 [Registered on: 14/12/2009] |
| Last Modified On: |
29/10/2018 |
| 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, zaltoprofen and diclofenac in patients with osteoarthritis of knee. |
Scientific Title of Study
Modification(s)
|
Comparative Evaluation of Efficacy and Safety of Zaltoprofen and Diclofenac in Patients with Knee Osteoarthritis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Ipca/ZPD/PIII-09, version date-25/05/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Ltd.,Mumbai |
| Address |
Plot.no.142, Kandivali Industrial Estate, Kandivali (W, Mumbai-400067
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-28686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
President, Medical Affairs & Clinical Research
142-AB, Kandivli Industrial Estate, Kandivli (West)
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-28686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitin Chandurkar |
| Designation |
General Manager |
| Affiliation |
Ipca Laboratories Ltd. |
| Address |
Ipca Laboratories Ltd,142AB, Kandivli Industrial Estate, Kandivli(W), Mumbai
Mumbai
MAHARASHTRA
400067
India
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02261112318 |
| Fax |
022-28686954 |
| Email |
nitin.chandurkar@ipca.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ipca Laboratories Limited, 142-AB, Kandivli Industrial Estate, Kandivli (West) Mumbai: 400067 |
|
Primary Sponsor
Modification(s)
|
| Name |
Ipca Laboratories Limited |
| Address |
Plot-142, Kandivali Industrial Estate, Kandivali (W),Mumbai |
| 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. Amit Swamy |
Dr. DY Patil Medical College |
,-411018
Pune
MAHARASHTRA |
09823175493
amit.swamy@gmail.com |
| Dr. Ashish Sirsikar |
GR Medical College & JA Group of Hospitals |
,-474009
Gwalior
MADHYA PRADESH |
09406972205
ashish_sirsikar@rediffmail.com |
| Dr. Ratnakar Ambade |
Indira Gandhi Medical College |
,-400018
Nagpur
MAHARASHTRA |
09823033511
'ambade_rnv@hotmail.com' |
| Dr. Anil Gupta |
Mahatma Gandhi Medical College |
,-302022
Jaipur
RAJASTHAN |
09887501594
drguptaanil2004@yahoo.co.in |
| Dr. Bhavesh Jesalpura |
Sheth VS General Hospital |
,-380006
Ahmadabad
GUJARAT |
09824370399
bjesalpura@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGMC, Nagpur |
Approved |
| Mahatma Gandhi Medical College & Hospital, Jaipur |
Approved |
| Office of the Dean GR Medical College, Gwalior |
Approved |
| Padmashree Dr. DY Patil Medical College & Hospital, Pimpri, Pune |
Approved |
| Sheth VS General Hospital, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of Knee, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac |
50 mg tablets thrice a day for 28 days |
| Intervention |
Zaltoprofen |
80 mg tablets thrice a day oral for 28 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged 40 to 65 years
2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition
3. Patients with primary knee osteoarthritis confirmed by X-rays
4. Patients satisfying American college of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of Knee
5. Patients fulfilling the ACR criteria for classification of functional status from class I, II or III
6. Patients with symptomatic osteoarthritis for at least 3 months with moderate pain intensity score
7. Patients with moderately severe symptomatic OA determined on the WOMAC scale
8. Patients willing and likely to fully comply with study procedures and restrictions and ready give to written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients with secondary osteoarthritis
2. Patients with history of peptic ulcers, duodenal ulcers, gastro intestinal bleeding or bleeding disorders
3. Patients with abnormal renal and liver function
4. Patients with significant medical illness
5. Patient having any concomitant medication, which may interact with action of study drugs.
6. Patients with known history of hypersensitivity to NSAIDS, zaltoprofen or any other ingredient of the study medication or other similar drugs of same chemical class
7. Pregnant or lactating women
8. Women of childbearing potential not practicing contraception |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Double Blind Double Dummy |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean fall in pain intensity |
At day 7, day 14, day 21 and day 29 from baseline |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Number of paracetamol tablets consumed |
Day 7, Day 14, Day 21 & Day 29 |
| Number of antacid tablets consumed |
Day 7, Day 14, Day 21 & Day 29 |
| Safety and toleability of study medication |
throughout the duration of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
31/12/2009 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Expert Opin. Pharmacother. (2011)12 (7):1007:1015 |
|
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 randomized, double blind, parallel group, multi-centre trial comparing the efficacy and safety of zaltoprofen 80 mg t.i.d. and diclofenac 50 mg t.i.d. for 28 days in patients with knee osteoarthritis. The primary outcome will be mean fall in pain intensity and WOMAC index at day 7, day 14, day 21 & day 29 from baseline and comparison of average pain relief score at day 7, day 14, day 21 and day 29. Secondary outcomes are comparison of number of paracetamol and antacid tablet consumption and safety and tolerability of study medications. |