Health Condition 1: null- Osteoarthritis of Knee Health Condition 2: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Zaltoprofen: 80 mg tablets thrice a day oral for 28 days
Control Intervention1: Diclofenac: 50 mg tablets thrice a day for 28 days
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean fall in pain intensityTimepoint: At day 7, day 14, day 21 and day 29 from baseline;Mean fall in pain intensityTimepoint: At day 7, day 14, day 21 and day 29 from baseline;Mean fall in pain intensityTimepoint: At day 7, day 14, day 21 and day 29 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of antacid tablets consumedTimepoint: Day 7, Day 14, Day 21 & Day 29;Number of paracetamol tablets consumedTimepoint: Day 7, Day 14, Day 21 & Day 29;Safety and toleability of study medicationTimepoint: throughout the duration of study | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed