Efficacy and Safety of Aceclofenac Controlled Release in Patients with Knee Osteoarthritis: A 4-week, Multicenter, Randomized, Comparative Clinical Study

Abstract

PurposeTo evaluate the analgesic effect, efficacy and safety of aceclofenac controlled release (CR) in patients with chronic knee osteoarthritis (OA).Materials and MethodsA total of 125 subjects with chronic knee OA were randomly divided into two groups: one group (n=62) was administered aceclofenac CR once daily and the other (n=63), aceclofenac immediate release (IR) twice a day for 4 weeks. A 100-mm visual analogue scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS) and range of motoin (ROM) were evaluated as the outcome measures. To evaluate the safety of the drug, adverse events, vital signs, physical examination findings, clinical laboratory values and electrocardiographic findings were evaluated.ResultsThe VAS, KOOS and ROM were improved after 4 weeks of administration in both groups, but the differences between the two groups were not statistically significant. Significant differences between the two groups were not shown in the evaluation of the adverse events, vital sign, physical examination results, clinical laboratory values, and electrocardiography.ConclusionsThe aceclofenac CR and aceclofenac IR were equally effective in patients with chronic knee OA and the clinical trial results didn't show any significant difference in safety. The new aceclofenac CR formulation was found to be effective and safe with the practical advantage of once daily administration.

Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial

“…To calculate sample size required to evaluate non-inferiority between pelubiprofen CR 90 mg and aceclofenac 200 mg for clinical efficacy, the following conditions were used: statistical power, 1-ß = 0.975; level of significance, a one-sided α = 0.025. We set the non-inferiority margin of the difference between pelubiprofen CR 90 mg and aceclofenac 200 mg to 15 mm of the VAS score ranging from 0 to 100 mm [ 13 ]. The sample size for each group required for a confidence interval of 95% and power of 97.5% was calculated using the following formula: …”

Use of Non-Steroidal Anti-Inflammatory Drugs in Osteoarthritis: a Sight Through the Prism of Pathogenesis

“…В обеих группах наблюдалось достоверное уменьшение уровня боли и улучшение сгибания в коленном суставе по окончании терапии. Нежелательные реакции чаще регистрировались среди пациентов, принимавших ацеклофенак с контролируемым высвобождением, -22,8% против 12,1% в группе, принимавшей обычный ацеклофенак (р = 0,129) [58]. Результаты еще одного сравнительного исследования двух форм ацеклофенака, выполненного J.H.…”

Safety and tolerability of nsaids: focus on aceclofenac

“…РКИ с участием пациентов с остеоартритом коленных суставов и болью в спине подтвердили сопоставимую эффективность и безопасность ацеклофенака короткого действия и лекарственной формы с модифицированным высвобождением действующего вещества [99][100][101][102], причем пациенты, принимавшие лекарственную форму Clanza, использовали меньше таблеток парацетамола и ранитидина, что может быть косвенным признаком ее несколько большей эффективности и лучшей переносимости [99]. Аналогичные результаты получены и в 14 отечественных исследованиях с участием около 5 000 пациентов [103,104].…”