Skip to content

To study the effect of Polmacoxib versus Aceclofenac and Paracetamol combination on pain in knee Osteoarthritis.

A randomized open label study to assess efficacy and safety of Polmacoxib versus Aceclofenac and Paracetamol combination in patients with Osteoarthritis of knee. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/078878
Enrollment
40
Registered
2025-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: polmacoxib: Oral Polmacoxib 2 mg once daily morning after food for 10 days Control Intervention1: aceclofenac and Paracetamol combination: Oral Aceclofenac 100mg + Paracetamol 325mg twi

Sponsors

Dr Nagur Sharone Grace
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Osteoarthritis involving unilateral or bilateral knees,Patients with radiographic osteoarthritic changes of grade 1 to 3 of Kellgren and Lawrence system of osteoarthritis classification, WOMAC Pain subscale score range of 5-15

Exclusion criteria

Exclusion criteria: History of Hypersensitivity to NSAIDS, Carbonic anhydrase inhibitors; Patients on corticosteroids, opioids, Selective Serotonin Reuptake Inhibitors, benzodiazepines, antipsychotics, anticoagulants, antiplatelets, Angiotensin Converting Enzyme Inhibitors, Angiotensin Receptor Blockers;Patients with medical history of peptic ulcer disease, GI bleeding, coagulant disorder, any cardiovascular disease; 6. Any medical condition or comorbidities, which in the clinician/investigator opinion could affect the safety and wellbeing of participants.

Design outcomes

Primary

MeasureTime frame
Change in the WOMAC-Pain Subscale between the groupsTimepoint: 10 days

Secondary

MeasureTime frame
Change in the WOMAC OA index between, within the groups; Any ADRs with study drugs Timepoint: 10 days

Countries

India

Contacts

Public ContactDr N Sharone Grace

Nizams Institute of Medical Sciences

ushapingali@yahoo.com9885421147

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026