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RECRUITING
NCT07372924
PHASE2

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

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-24

Completion Date

2026-07

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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

Locations (2)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, Wuhan, China