Efficacy and Safety Studies of Oliceridine Fumarate

June 8, 2024 updated by: Chun Pan

Efficacy and Safety Study of Oliceridine Fumarate Versus Remifentanil for Analgesic Therapy in Mechanically Ventilated Subjects in the ICU

The objective of this clinical trial is to investigate the efficacy and safety of oliceridine fumarate for analgesic treatment in mechanically ventilated subjects in the ICU. This study was conducted to answer the following questions (1) the efficacy of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation (2) the safety of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation. This study proposes to conduct a randomized controlled clinical trial in mechanically ventilated patients in the intensive care unit to compare the analgesic efficacy and incidence of adverse effects of two drugs, oliceridine fumarate injection and remifentanil. Subjects had an analgesic goal of CPOT <3 points and a sedation goal of RASS -2 to 0 points. Infusion syringes of remifentanil or oliceridine fumarate were prepared by a nurse according to the weight of the subjects. Subjects were enrolled in the group and were scored for analgesia and sedation related scores. Both groups received routine ICU monitoring and appropriate treatment, which was determined by the clinician.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 (Estimated)

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.
292

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 4

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 aged ≥18 years and ≤80 years;
  2. Admitted to the ICU and undergoing invasive mechanical ventilation with an expected duration of mechanical ventilation of more than 24 hours;
  3. Subjects requiring sedation and analgesia;
  4. Subjects or their guardians voluntarily participate in the study and sign an informed consent form;

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Hypersensitivity to opioids (fentanyl, remifentanil, sufentanil, morphine, etc.);
  3. Subjects with bronchial asthma attacks;
  4. Subjects with acute intestinal obstruction;
  5. Subjects who are unable to undergo RASS and CPOT assessments for various reasons, such as those with a history of psychiatric systemic disorders (schizophrenia, mania, psychosis, history of cognitive dysfunction), grand mal status epilepticus, and craniocerebral injury;
  6. Severe hemodynamic instability (subjects who require administration of more than an equivalent dose of 0.5 μg/kg/min norepinephrine to maintain a MAP ≥ 65 mmHg and who, in the opinion of the investigator, are not suitable for enrollment);
  7. Use of monooxygenase inhibitors (MAOIs) (see protocol appendix);
  8. Chronic pain requiring long-term analgesic medication (duration of illness greater than 3 months);
  9. Severe hepatic insufficiency (liver function in Child classification C);
  10. Severe renal dysfunction (definition of renal dysfunction: chronic renal insufficiency [glomerular filtration rate (GFR) ≦29ml/(min1.73m3]; or long-term maintenance hemodialysis or peritoneal dialysis subjects);
  11. Undergoing any clinical trial within 1 month prior to enrollment and receiving the test product;
  12. ECG QT interval at screening: >450 ms for men and >470 ms for women;
  13. Subjects with a desired sedation target RASS score within the range of -5 to -3 (including threshold) points;
  14. Other conditions deemed unsuitable for enrollment by the investigator.

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: Single

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: Intervention group：Oliceridine Fumarate
Drug: Oliceridine Fumarate
After subjects were enrolled, the original sedative and analgesic drugs were discontinued, and a starting dose of 6ug/kg/h of oliceridine fumarate was continuously pumped, and the time of oliceridine fumarate initiation was recorded as T0. Subjects were assessed for sedation using the RASS score, and for analgesia using the CPOT score. Waiting for the original sedative-analgesic drug to elute until CPOT ≥ 3 and RASS > 0. Adjust the infusion rate of oliceridine fumarate according to the CPOT score (recommended to be adjusted by 2ug/kg/h, the range of adjustment is 2-20 ug /kg/h, and the maximum infusion rate is not more than 20 ug /kg/h) until the analgesic score of the subject is CPOT<3. The interval between two trial drug rate adjustments should be ≧5 min, and a CPOT score should be performed before each drug adjustment.
Experimental: Control group: Remifentanil
Drug: Remifentanil
After subjects were enrolled, the original sedative and analgesic drugs were discontinued, and remifentanil was continuously pumped at a starting dose of 1.5ug/kg/h. The time of remifentanil initiation was recorded as T0. Subjects were assessed for sedation using the RASS score and analgesia using the CPOT score. We waited for the original sedative-analgesic drugs to elute until CPOT ≥ 3 and RASS > 0. The infusion rate of remifentanil was adjusted according to the CPOT score (1.5ug/kg/h is recommended, the range of adjustment is 1.5~12μg/kg/h, and the maximum infusion rate is not more than 12μg/kg/h) until the subject's analgesic score of CPOT<3, and the interval between the two experimental rate adjustments of the drug should be ≧5min, and the CPOT score should be performed before each adjustment of the drug. The CPOT score should be performed before each drug adjustment.

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
Measure Description
Time Frame
Assessment of analgesic effectiveness
Time Frame: Not more than 3 days
Percentage of time to achieve analgesic goal as a percentage of total time on medication during the study drug efficacy period (analgesic goal was CPOT <3 points, and the start of recording was the time of initiation of medication).
Not more than 3 days

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.
Chun Pan

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 (Estimated)

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.
June 1, 2024

Primary Completion (Estimated)

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.
December 1, 2025

Study Completion (Estimated)

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.
December 1, 2025

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).
June 2, 2024

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.
June 8, 2024

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.
June 12, 2024

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.
June 12, 2024

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.
June 8, 2024

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.
June 1, 2024

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.
  • 2024-10 (Other Identifier: The Reasearch Ethics Board of the Faroe Islands)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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