Prospective, Real-World, Open-Label, Longitudinal Study on the Effectiveness of Fixed-Dose Combination of Naproxen and Paracetamol 275/325 mg/tablet among Filipino Patients with Osteoarthritis, A Phase IV Study

ABSTRACT

Introduction

Osteoarthritis (OA) is a prevalent degenerative joint condition that significantly impacts mobility and quality of life. This study investigates the effectiveness and safety of a fixed-dose combination of naproxen and paracetamol in reducing pain scores among Filipino patients with OA.

Methodology

This observational, open-label, non-blinded phase 4 clinical trial included adult patients over 18 years old with mild to moderate OA-related pain. Participants were prescribed a fixed-dose combination of naproxen (275 mg) and paracetamol (325 mg) taken twice daily for five days. Pain scores were assessed at baseline and follow-up using a visual analog scale. Secondary endpoints included medication adherence and the incidence of adverse events. Wilcoxon matched-pairs signed-rank test was used for statistical analysis.

Results

A total of 67 patients participated, with a mean age of 58 years. There was a statistically significant reduction in pain scores at rest (52.9%) and during movement (45.85%) after five days (p < 0.001). Complete pain resolution was achieved in 31.34% of patients at rest and 10.45% during movement. The combination therapy was well-tolerated, with three mild adverse events (skin rash, abdominal pain, and palpitations), all resolving without further treatment.

Conclusion

The fixed-dose combination of naproxen and paracetamol was effective in reducing pain associated with osteoarthritis, showing early onset of pain relief and a favorable safety profile. This combination offers a promising option for managing osteoarthritis pain, providing significant analgesic benefits while minimizing the risks associated with higher doses of NSAIDs, making it particularly suitable for elderly patients.