A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain

Summary

This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.

Timeline

Start

2020-05-12

Primary completion

2022-12-20

Completion

2022-12-20

Outcome

Met primary endpoint

paper with the upper limit of the 95 % confidence interval [-5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm. PMID 39018898 ↗

Publications

• Joung KH, Kim TN, Ku EJ, Lee SS, Yoo WS, Park KS, Kwon SK, Ku BJ. A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain. J Diabetes Complications. 2024 Aug;38(8):108809. doi: 10.1016/j.jdiacomp.2024.108809. Epub 2024 Jul 14.

Drugs

Indications