Dual release paracetamol in osteoarthritis of knee: a randomized controlled clinical trial

Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA. In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient's and physicians global assessment of therapy were included as secondary endpoints. Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p