Health Condition 1: M160- Bilateral primary osteoarthritis of hip Health Condition 2: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Polmacoxib 2 mg: Once daily after breakfast for 6 weeks
Control Intervention1: NA: Not required
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females patients 18 years or above, who are able and willing to provide written informed consent. 2. Knee or Hip OA diagnosed according to clinical and imaging criteria specified by the American College of Rheumatology guidelines. 3. Patients with chronic pain for >= 3 months from OA. 4. Patients with radiographic osteoarthritic changes of grade >=2 of Kellgren and Lawrence system of osteoarthritis classification1 5. Patients with index joint pain of at least moderate to severe intensity as measured by visual analog scale (VAS) recording of >=40 mm (0â??100 mm) 6. Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period and for 3 months afterward and neither become pregnant or lactate.
Exclusion criteria
Exclusion criteria: 1. Patients with history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol. 2. Patients with medical conditions of active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to screening. 3. Patients with History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock. 4. Patients with history of congestive heart failure with a status of New York Heart Association II-IV, ischemic heart disease, uncontrolled hypertension (controlled hypertension for more than 3 months prior to screening are eligible), peripheral arterial disease, cerebrovascular disease. 5. Patients with a recent history (1 year) of drug or alcohol abuse (2 or less drinks per day allowed) or dependence 6.Patients who are not suitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent clinical & laboratory adverse events (TEAEs) during the treatment period.Timepoint: week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline to Week 6 in the WOMAC Total OA Index and Subscales Scores. Timepoint: week 6;2. Change from baseline to Week 6 in Pain Score measured by VAS scale.Timepoint: Week 6;Change from baseline to Week 6 in Subjects Global AssessmentTimepoint: Week 6;Change from baseline to Week 6 in Physicians Global AssessmentTimepoint: Week 6 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Drugs Limited
Outcome results
None listed