Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial.

PURPOSE: This study compared the efficacy and safety of controlled-release pregabalin (GLA5PR GLARS-NF1 tablets) with those of an immediate-release pregabalin capsule after 12 weeks' administration to patients with peripheral neuropathic pain. METHODS: In this multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III study, the primary outcome was to confirm that a single treatment with the study drug (after the evening meal) is clinically noninferior to the control drug (BID regimen) at improving the mean Daily Pain Rating Scale score for treating peripheral neuropathic pain. Secondary outcomes were the Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, Hospital Anxiety and Depression scale, and frequency of rescue medication use. The safety and tolerability of GLA5PR GLARS-NF1 tablets were also evaluated. The total daily dose of pregabalin is 150-600 mg. FINDINGS: Of the 352 randomized subjects, 261 (n = 130, study group; n = 131, control group) were analyzed. The difference in adjusted mean Daily Pain Rating Scale scores between the groups was -0.11 (95% confidence interval, -0.05 to 0.30), indicating that the study group is noninferior to the control group. There was no statistically significant difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores between the groups at treatment termination. Logistic regression analysis revealed no significant difference in the use of rescue medication between the groups (P = 0.217). The overall adverse event profile of the groups was similar, and no serious adverse drug reactions were observed. IMPLICATIONS: GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression were improved with pain control. Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907.