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This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | HSK3486 for induction of general anesthesia. |
|
| Propofol | Active Comparator | Propofol for induction of general anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | HSK3486 for induction of general anesthesia. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Anesthesia Induction | The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone. | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' NRS Pain Score | Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain). Subjects' NRS pain score at the time of study drug administration (Day 1) and recall of pain score in PACU. | Up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the Disappearance of Eyelash Reflex | Time from the end of the first administration of the study drug to the disappearance of eyelash reflex. | From end of drug administration to disappearance of eyelash reflex (up to 5 minutes) |
| Number of Participants That Failed to Meet Successful Induction of General Anesthesia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Daley, MD | Haisco-USA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Lotus Clinical Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | HSK3486 | HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia. |
| FG001 | Propofol | Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2021 | Mar 28, 2023 |
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| Propofol |
| Drug |
Propofol for induction of general anesthesia. |
|
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| Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. |
The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression between the time of successful induction and 15 minutes post initiation of study drug administration, or up to the beginning of second tracheal intubation attempt if it is a difficult condition and not beyond 15 minutes post initiation of study drug administration. |
| 15 minutes from end of drug administration. |
| Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. | The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1). | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
| Time to Successful Induction of General Anesthesia. | Time from the end of the first administration of the study drug to MOAA/S ≤1. | From end of drug administration to MOAA/S ≤1 (up to 5 minutes) |
Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs |
| From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
| Pasadena |
| California |
| 91105 |
| United States |
| Phoenix Clinical Research, LLC | Tamarac | Florida | 33321 | United States |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| New York City Heath and Hospitals | New York | New York | 10013 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| UNC Health Care System | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| The Ohio State University Research Foundation | Columbus | Ohio | 43210 | United States |
| HD Research | Bellaire | Texas | 77401 | United States |
| Plano Surgical Hospital | Plano | Texas | 75093 | United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HSK3486 | HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia. |
| BG001 | Propofol | Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Anesthesia Induction | The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone. | Posted | Count of Participants | Participants | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
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| Secondary | Subjects' NRS Pain Score | Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain). Subjects' NRS pain score at the time of study drug administration (Day 1) and recall of pain score in PACU. | Full Analysis Set (FAS): All randomized subjects who have received at least 1 dose of the study drug (HSK3486 or propofol). | Posted | Count of Participants | Participants | Up to 8 hours |
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| Secondary | Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. | The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression between the time of successful induction and 15 minutes post initiation of study drug administration, or up to the beginning of second tracheal intubation attempt if it is a difficult condition and not beyond 15 minutes post initiation of study drug administration. | Induction of General Anesthesia | Posted | Count of Participants | Participants | 15 minutes from end of drug administration. |
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| Secondary | Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. | The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1). | Posted | Count of Participants | Participants | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
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| Secondary | Time to Successful Induction of General Anesthesia. | Time from the end of the first administration of the study drug to MOAA/S ≤1. | Time to successful induction of general anesthesia was defined as the time from the end of first administration of the study drug to the time when MOAA/S was ≤1. | Posted | Median | 95% Confidence Interval | minutes | From end of drug administration to MOAA/S ≤1 (up to 5 minutes) |
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| Other Pre-specified | Time to the Disappearance of Eyelash Reflex | Time from the end of the first administration of the study drug to the disappearance of eyelash reflex. | Time to loss of eyelash reflex was defined as the time from the end of the first administration of the study drug to the time when eyelash reflex was lost. | Posted | Median | 95% Confidence Interval | minutes | From end of drug administration to disappearance of eyelash reflex (up to 5 minutes) |
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| Other Pre-specified | Number of Participants That Failed to Meet Successful Induction of General Anesthesia | Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs | Posted | Count of Participants | Participants | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) |
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Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HSK3486 | HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia. | 0 | 168 | 0 | 168 | 47 | 168 |
| EG001 | Propofol | Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia. | 0 | 83 | 3 | 83 | 27 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Cardiac disorders | The MedDRA V 25 | Systematic Assessment |
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| Abdominal Wall Haematoma | Gastrointestinal disorders | The MedDRA V 25 | Systematic Assessment |
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| Femur Fracture | Musculoskeletal and connective tissue disorders | The MedDRA V 25 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | The MedDRA Version 2 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | The MedDRA Version 2 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | The MedDRA Version 2 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yu-Ling Lai Senior Director Clinical Operations | Haisco USA Pharmaceutical Inc. | 1 732-26-4759 | Yuling.lai@Haisco-usa.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2021 | Mar 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000730813 | HSK3486 |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Proportion of NRS = 0 Pain score |
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| Missing NRS |
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