Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Etoricoxib 90 mg: Etoricoxib 90 mg
Route Oral,
Frequency Once daily
Duration 4 weeks
Control Intervention1: Diclofenac Sodium 50 mg: Diclofenac Sodium Dose: 50 mg Route Oral Frequency
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Provision of written informed consent before any study related procedure.Age more than 40 years at the time of informed consent Confirmed primary osteoarthritis of the knee or hip Symptomatic knee or hip osteoarthritis for more than 3 months prior to screening or baseline Overall, Pain score greater than or equal to 4 and equal to or less than 9 at baseline on 0 to 10 NRS Treatment na ve for osteoarthritis analgesic therapy or no NSAID use within the previous 48 to 72 hours before baseline assessment or randomization Negative pregnancy test Willingness to comply with study procedures and scheduled visits Ability to understand and complete study questionnaires in the applicable language
Exclusion criteria
Exclusion criteria: Inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, or systemic lupus erythematosus. Active gout flare or other acute inflammatory joint condition. Fibromyalgia or another dominant pain condition that may interfere with effectiveness assessment. Active peptic ulcer disease or history of gastrointestinal bleeding, perforation, or obstruction. Uncontrolled hypertension. Clinically significant cardiovascular disease or recent major cardiovascular event, in the investigator s judgment. Clinically significant hepatic impairment or renal impairment. Chronic opioid therapy. Intra-articular corticosteroid or viscosupplementation in the study joint within 3 months before enrolment. Planned surgery or intra-articular procedure involving the study joint during the study period. Known hypersensitivity, intolerance, or contraindication to etoricoxib, diclofenac, other NSAIDs, aspirin-sensitive asthma, or paracetamol. Any medical condition in which NSAIDs or paracetamol are contraindicated in the investigator s judgment. Pregnant women or women currently breast feeding Women of childbearing potential (WOCBP) who are unwilling to use highly effective ,medically accepted methods of contraception during the duration of the trial Participation in another clinical study within 30 days prior to enrolment. Any medical, psychiatric, or social condition that, in the investigator s opinion, may compromise participant safety, compliance, or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of etoricoxib 90 mg once daily versus diclofenac sodium 50 mg three times daily in reducing pain among patients with symptomatic knee or hip osteoarthritis, as assessed by change from baseline in Overall Pain score at Week 4Timepoint: Baseline and Week 4 / Day 28 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Pain in specific situations & Stiffness score PGART assessment at least 30 percent & at least 50 percent Overall Pain responder rates Pain while walking on a flat surface PGART approximately 4 hours after morning dose total rescue paracetamol consumption good or excellent PGART response & safety & tolerability assessment including AEs SAEs treatment related AEs GI symptoms BP changes edema cardiovascular symptoms or events & clinically significant LFT RFT & pregnancy test abnormalitiesTimepoint: Baseline Day 1 Day 2 Week 2 Day 14 plus or minus 2 days Week 4 Day 28 plus or minus 2 days & throughout the 4 week treatment period | — |
Countries
India
Contacts
Public ContactDr Jawahar Jethwa
Dr. Jawahar Jethwa Clinic
Outcome results
None listed