NCT05319275

Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN

A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by Diabetic Peripheral Neuropathy (DPN).

Detailed description

This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese patients with paresthesia caused by DPN.The trial included a 2-week screening period, a 1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up period.

Conditions

• Diabetic Peripheral Neuropathy (DPN)
• Paresthesia

Interventions

Type	Name	Description
DRUG	Acetyllevocarnitine Hydrochloride Tablets	500 mg (2×250 mg/tablet) after meal, 3 times per day
DRUG	Placebo	500 mg (2×250 mg/tablet) after meal, 3 times per day

Timeline

• Start date: 2020-07-23
• Primary completion: 2021-12-07
• Completion: 2022-01-25
• First posted: 2022-04-08
• Last updated: 2022-04-08

Locations

34 sites across 1 country: China