Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label

Ajay S Chandanwale,1 Subramanian Sundar,2 Kaliaperumal Latchoumibady,3 Swati Biswas,4 Mukesh Gabhane,4 Manoj Naik,5 Kamlesh Patel4 1Department of Orthopedics & Traumatology, Byramjee Jeejeebhoy Medical College and Sassoon General Hospital, Pune, Maharashtra, India; 2Vasantha Subramanian Hospital, Chennai, Tamil Nadu, India; 3Vijay Hospital, Pondicherry, India; 4Medical Services Department, 5Clinical Research Department, Abbott Healthcare Pvt Ltd, Mumbai, India Objective: We aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain. Methods: A total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.5 mg) and paracetamol (325 mg) (two tablets every 4–6 hours, up to a maximum of eight tablets daily). The primary efficacy end points were reductions in pain intensity from baseline at day 3 and day 5 as assessed by a Visual Analog Scale (VAS) score. Results: Group A showed a significant reduction in the VAS score for overall pain from baseline on day 3 (P=0.001) and day 5 (P