Abirritation in the ICUPhase 2NCT07372924

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

A Phase 2 study testing Tegileridine Fumarate lnjection and Remifentanil Hydrochloride for Injection in people with Abirritation in the ICU, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Abirritation in the ICU
What is being tested?: Tegileridine Fumarate lnjection and Remifentanil Hydrochloride for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 2 sitesChina
Study dates: 24 Feb 2026to 14 Aug 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
With an expected survival time of less than 48 hours
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
Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
Multiple organ failure
Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization

Show all 20Show fewer

Chronic pain requires long-term use of analgesics
Severe liver dysfunction
Severe renal dysfunction
Severe renal dysfunction
Need to receive deep sedation or use neuromuscular blocking drugs
Surgery or tracheotomy may be required during the study administration period
Used monoamine oxidase inhibitors within the two weeks randomization
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
QTc abnormality during screening period
Positive result for infectious disease
Positive screening for drug abuse
Pregnant or nursing women;
Subjects who has Participated in any other clinical trials within the first 3 months of randomization
Other conditions deemed unsuitable to be included.

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

Other trials in China

About this study

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)

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
Being tested: Tegileridine Fumarate lnjection, Remifentanil Hydrochloride for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tegileridine Fumarate lnjectionDrug
Tegileridine Fumarate lnjection; low dose
Tegileridine Fumarate lnjectionDrug
Tegileridine Fumarate lnjection; high dose
Remifentanil Hydrochloride for InjectionDrug
Remifentanil Hydrochloride for Injection

Study groups in NCT07372924
Study group	Role	What they receive
Treatment group A: Tegileridine Fumarate lnjection	Experimental	Not described Receives: Drug: Tegileridine Fumarate lnjection
Treatment group B: Tegileridine Fumarate lnjection	Experimental	Not described Receives: Drug: Tegileridine Fumarate lnjection
Treatment group C: Remifentanil Hydrochloride for Injection	Active comparator	Not described Receives: Drug: Remifentanil Hydrochloride for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.
Measured: within 3 days after administration of research drug

Secondary outcomes (7)

Percentage of time maintaining target abirritation in the entire drug administering time.
Measured: within 3 days after administration of research drug
Percentage of subjects receiving rescue analgesic drug
Measured: within 3 days after administration of research drug
The total dosage of rescue analgesic drug
Measured: within 3 days after administration of research drug
Receiving the total dosage of sedation
Measured: within 3 days after administration of research drug
Nursing Scores
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.
Measured: within 3 days after discontinuation of research drug
Mechanical ventilation time.
Measured: From research drug administration to actual extubation , up to 72 hours
Extubation time
Measured: From discontinuation of research drug to actual extubation , up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202614 Aug 2026

First posted28 Jan 2026
Study start24 Feb 2026
Primary completion14 Aug 2026
Study completion14 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Abirritation in the ICUStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07372924
Sponsor's protocol ID: SHR8554-205
Status last verified: Nov 2025
First submitted: 4 Jan 2026
Last updated: 28 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07372924
Acronym / sponsor ID: SHR8554-205
Conditions: Abirritation in the ICU
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 24 Feb 2026 (actual)
Primary completion: 14 Aug 2026 (actual)
Study completion: 14 Aug 2026 (actual)
First posted: 28 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment group A: Tegileridine Fumarate lnjection	Experimental	Drug: Tegileridine Fumarate lnjection
Treatment group B: Tegileridine Fumarate lnjection	Experimental	Drug: Tegileridine Fumarate lnjection
Treatment group C: Remifentanil Hydrochloride for Injection	Active comparator	Drug: Remifentanil Hydrochloride for Injection

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (20 listed)

Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
With an expected survival time of less than 48 hours
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
Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
Multiple organ failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tegileridine Fumarate lnjectionTegileridine Fumarate lnjection; low dose	Drug	Treatment group A: Tegileridine Fumarate lnjection
Tegileridine Fumarate lnjectionTegileridine Fumarate lnjection; high dose	Drug	Treatment group B: Tegileridine Fumarate lnjection
Remifentanil Hydrochloride for InjectionRemifentanil Hydrochloride for Injection	Drug	Treatment group C: Remifentanil Hydrochloride for Injection

Primary outcome

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

7 secondary outcomes

Percentage of time maintaining target abirritation in the entire drug administering time.
Time frame: 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
The total dosage of rescue analgesic drug
Time frame: within 3 days after administration of research drug
Receiving the total dosage of sedation
Time frame: within 3 days after administration of research drug
Nursing Scores
Time frame: within 3 days after discontinuation of research drug
Mechanical ventilation time.
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07372924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.