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

August 27, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Zhongshan hospital
    • Wuhan
      • Hubei, Wuhan, China, 430015
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients or their guardians are able to provide a written informed consent
  2. Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
  3. Age ≥ 18 and ≤ 85 years, Male or female
  4. Body mass index (BMI) > 18 and < 30 kg/m2
  5. Use of highly effective contraception for a specified period if applicable

Exclusion Criteria:

  1. Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
  2. With an expected survival time of less than 48 hours
  3. unable to undergo CPOT and RASS assessments due to various reasons, such as a history of psychiatric disorders, neurological disorders, neurological dysfunction, and consciousness disorders, as well as blindness, deafness, or aphasia
  4. Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
  5. Multiple organ failure
  6. Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
  7. Chronic pain requires long-term use of analgesics
  8. Severe liver dysfunction
  9. Severe renal dysfunction
  10. Severe renal dysfunction
  11. Need to receive deep sedation or use neuromuscular blocking drugs
  12. Surgery or tracheotomy may be required during the study administration period
  13. Used monoamine oxidase inhibitors within the two weeks randomization
  14. History of drug abuse, drug use, alcohol abuse, and long-term use of psychotropic drugs within 2 years prior to the start of the screening period
  15. QTc abnormality during screening period
  16. Positive result for infectious disease
  17. Positive screening for drug abuse
  18. Pregnant or nursing women;
  19. Subjects who has Participated in any other clinical trials within the first 3 months of randomization
  20. Other conditions deemed unsuitable to be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A: Tegileridine Fumarate lnjection
Drug: Tegileridine Fumarate lnjection
Tegileridine Fumarate lnjection; low dose
Drug: Tegileridine Fumarate lnjection
Tegileridine Fumarate lnjection; high dose
Experimental: Treatment group B: Tegileridine Fumarate lnjection
Drug: Tegileridine Fumarate lnjection
Tegileridine Fumarate lnjection; low dose
Drug: Tegileridine Fumarate lnjection
Tegileridine Fumarate lnjection; high dose
Active Comparator: Treatment group C: Remifentanil Hydrochloride for Injection
Drug: Remifentanil Hydrochloride for Injection
Remifentanil Hydrochloride for Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.
Time Frame: within 3 days after administration of research drug
within 3 days after administration of research drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of time maintaining target abirritation in the entire drug administering time.
Time Frame: within 3 days after administration of research drug
within 3 days after administration of research drug
Percentage of subjects receiving rescue analgesic drug
Time Frame: within 3 days after administration of research drug
within 3 days after administration of research drug
The total dosage of rescue analgesic drug
Time Frame: within 3 days after administration of research drug
within 3 days after administration of research drug
Receiving the total dosage of sedation
Time Frame: within 3 days after administration of research drug
within 3 days after administration of research drug
Nursing Scores
Time Frame: within 3 days after discontinuation of research drug
The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3.
within 3 days after discontinuation of research drug
Mechanical ventilation time.
Time Frame: From research drug administration to actual extubation , up to 72 hours
From research drug administration to actual extubation , up to 72 hours
Extubation time
Time Frame: From discontinuation of research drug to actual extubation , up to 72 hours
From discontinuation of research drug to actual extubation , up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR8554-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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