NCT06383702

A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Pregabalin Sustained-Release Tablets for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled trial, the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. The study includes a screening period (3 weeks, including baseline/run-in period), a treatment period (titration period, fixed dose period and withdrawal period), and a follow-up period. During the treatment period participants will receive pregabalin sustained-release tablets/placebo as daily treatment.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	pregabalin sustained-release tablets	Subjects will take pregabalin sustained-release tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.
DRUG	Placebo	Subjects will take placebo tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-04-01
• Completion: 2025-04-15
• First posted: 2024-04-25
• Last updated: 2024-04-30