NCT07372924

A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

A Phase II, Multicenter, Randomized, Single-Blind, Dose Exploration, Positive Comparator Study to Evaluate the Efficacy and Safety of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.

Conditions

• Abirritation in the ICU

Interventions

Type	Name	Description
DRUG	Tegileridine Fumarate lnjection	Tegileridine Fumarate lnjection; low dose
DRUG	Tegileridine Fumarate lnjection	Tegileridine Fumarate lnjection; high dose
DRUG	Remifentanil Hydrochloride for Injection	Remifentanil Hydrochloride for Injection

Timeline

• Start date: 2026-02-24
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-01-28
• Last updated: 2026-03-13

Locations

2 sites across 1 country: China