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Clinical Trial Summary

This study aims to evaluate the safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets for the treatment of patients with diabetic peripheral neuropathy (DPN) in China.


Clinical Trial Description

This is a randomized, multi-center, double-blind, parallel-group, placebo-controlled, phase II clinical trial to evaluate safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets in DPN patients. A total number of 135 patients will be randomized (2:2:1) into three groups. Patients between 18 and 75 years old and diagnosed with a Distal Symmetric Polyneuropathy (DSPN) prior to study enrolment will be enrolled. The study consists of 4 stages: a 2-week screening period, a 1-week placebo introduction period, a 16-week randomized double-blind treatment period, and a 2-week post-study follow-up period. The overall planned duration of this study is approximately 21 weeks. ;


Study Design


Related Conditions & MeSH terms

  • Distal Symmetric Polyneuropathy (DSPN)
  • Peripheral Nervous System Diseases
  • Polyneuropathies

NCT number NCT05116111
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Xinhua Xiao, Professor
Phone +86-13911830085
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 31, 2021
Completion date June 15, 2023

See also
  Status Clinical Trial Phase
Completed NCT01261442 - Can Ultrasound Detect Diabetic Peripheral Neuropathy? N/A