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
| Autor: | Mukesh Gabhane, Manoj Naik, Subramanian Sundar, Ajay S Chandanwale, Kamlesh Patel, Kaliaperumal Latchoumibady, Swati Biswas |
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| Rok vydání: | 2014 |
| Předmět: |
Visual analogue scale
Nausea business.industry tramadol and diclofenac combination Osteoarthritis medicine.disease Epigastric pain Anesthesiology and Pain Medicine Diclofenac moderate to severe pain Anesthesia Rheumatoid arthritis medicine Tramadol Hydrochloride Tramadol Journal of Pain Research medicine.symptom business Original Research medicine.drug |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| DOI: | 10.2147/jpr.s67817 |
| Popis: | Ajay S Chandanwale,1SubramanianSundar,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 |
| Databáze: | OpenAIRE |
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