A clinical trial to study the effects of two drugs, zaltoprofen and diclofenac in patients with osteoarthritis of knee.

Phase 3

Completed

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2009/091/000928
• Lead Sponsor: Ipca Laboratories Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-31
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with secondary osteoarthritis2.
• Patients with history of peptic ulcers, duodenal ulcers, gastro intestinal bleeding or bleeding disorders3.
• Patients with abnormal renal and liver function4.
• Patients with significant medical illness5.
• Patient having any concomitant medication, which may interact with action of study drugs.
• 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 women8.
• Women of childbearing potential not practicing contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean fall in pain intensity	At day 7, day 14, day 21 and day 29 from baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Dr. DY Patil Medical College; 🇮🇳 Pune, MAHARASHTRA, India

GR Medical College & JA Group of Hospitals; 🇮🇳 Gwalior, MADHYA PRADESH, India

Indira Gandhi Medical College; 🇮🇳 Nagpur, MAHARASHTRA, India

Mahatma Gandhi Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

Sheth VS General Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. DY Patil Medical College

🇮🇳Pune, MAHARASHTRA, India

Dr. Amit Swamy

Principal investigator

09823175493

amit.swamy@gmail.com