Health Condition 1: M169- Osteoarthritis of hip, unspecified
Conditions
Interventions
Intervention1: Polmacoxib 2mg Capsule: In this PMS patients patients with knee or hip osteoarthritis will receive Ppolmacoxib 2mg capsule, Once A Day, for a period of 6 weeks, as per the routine clin
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients in the age group of 20 to 70 years, with a clinical diagnosis of knee or hip osteoarthritis as per the discretion of investigators. 2.Patients having chronic pain for 3 months or more due to osteoarthritis. 3. The baseline (predose) mean WOMAC pain score in the index joint is between 4 and 8. 4. Patients willing to provide written informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Use of any analgesics except the study medication or acetaminophen 24 hours before study drug administration and during the study. 2. Use of anticoagulants within 2 weeks before study enrollment. 3. Use of corticosteroids, herbal medicines, traditional ayurvedic medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate within 3 months before study enrollment. 4. Requirement for knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study. 5. Hypersensitivity or allergy to NSAID. 6. Pregnant and lactating women. 7. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock; history of New York Heart Association stage II-IV congestive heart failure, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, and/or cerebrovascular disease; pregnancy, breast-feeding, or expecting conception within the duration of the study; active ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months before randomization; ongoing chronic symptoms or psychiatric disorders preventing compliance with study procedures, except for subjects who were physically healthy and had been receiving the specified allowed drugs for =3 months; use of corticosteroids, intra-articular steroids or hyaluronic acid injections within 1 month of screening; chemotherapy within 5 years. 8. Patients with any other conditions or diseases that the investigator considers inappropriate to enter the study as per prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The mean change in the pain subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritisTimepoint: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The mean change in the stiffness subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis. 2.The mean change in the physical function subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis. 3. The mean change in the total Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis.Timepoint: Week 3 and 6 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed