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

Phase 3

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of KneeHealth Condition 2: M179- Osteoarthritis of knee, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified