AnalgesiaPhase 2NCT04424251

Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Undergoing Elective Laparoscopic Surgery

A Phase 2 study testing Experimental: stage I：HSK21542 0.4 μg/kg, Experimental: stage I：HSK21542 1 μg/kg and Experimental: stage I：HSK21542 0.5μg/kg in people with Analgesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site 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

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Analgesia
What is being tested?: Experimental: stage I：HSK21542 0.4 μg/kg, Experimental: stage I：HSK21542 1 μg/kg and Experimental: stage I：HSK21542 0.5μg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteChina
Study dates: 2 Jul 2020to 5 Jan 2021
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 ≤ age ≤ 70 years old, with no gender requirement
American Society of Anesthesiologists (ASA) Class I-II
18 kg/m^2 ≤ BMI ≤ 40 kg/m^2
Subjects undergoing elective laparoscopic surgery under general anesthesia with an expected surgery duration of 1-5 h (inclusive)
Agree to participate in this trial and voluntarily sign the informed consent form;

Who cannot join

History of allergy to opioids, such as urticaria, or allergic to the intraoperative anesthetics prescribed in the protocol;
History or evidence of any one of the following diseases prior to screening:
History of cardiovascular diseases: Uncontrolled hypertension (systolic blood pressure [SBP] ≥ 170 mmHg and/or diastolic blood pressure [DBP] ≥ 105 without antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment), aneurysm, severe arrhythmia, heart failure, Adams-Stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena caval syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction in the last 6 months before screening, history of tachycardia/bradycardia requiring medication, and II-III degree atrioventricular block (excluding patients with pacemakers);
History of respiratory disorder: Severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe bronchostenosis, throat mass, history of (bronchial) tracheoesophageal fistula or airway tear, and severe respiratory tract infection in the last 2 weeks before screening;
History of disorders in the nervous and psychiatric system: History of craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, and history of cerebrovascular accidents; history of schizophrenia, mania, mental aberration, long-term use of psychotropic drugs, and cognitive disorder; history of depression, anxiety, and epilepsy, etc.;
Underwent major surgery within 3 months before screening and was judged by the investigator to have potential effect on the postoperative pain evaluation;

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Any of the following airway management risks during screening:
Acute asthma attacks;
Sleep apnea syndrome;
History or family history of malignant hyperthermia;
History of failed tracheal intubation;
Difficult airway (modified Mallampati score ≥ III) as determined by the investigator;
In receipt of any of the following drugs or therapies during the screening period:
The time between randomization and the last dose of opioid or non-opioid (such as acetaminophen, aspirin [daily dose of > 100 mg], indomethacin, diclofenac, parecoxib sodium and other non-steroidal anti-inflammatory drugs) analgesics is shorter than 5 half-lives of the drug or the duration of drug efficacy (whichever is longer);
Continuous use of opioid analgesics for more than 10 days for any reason within 3 months before screening;
Use of drugs that affect the analgesic effect within 14 days before randomization, including but not limited to: Sedative hypnotics (benzodiazepines [triazolam, diazepam, midazolam, etc.], non-benzodiazepines [zolpidem, zopiclone, zaleplon, etc.]), sedative anesthetics (sevoflurane, anesthesia ether, nitrous oxide, thiopental, ketamine, etomidate, etc.), glucocorticoids (dexamethasone hydrochloride , methylprednisolone, etc.), anti-epilepsy drugs (carbamazepine, sodium valproate, etc.), anxiolytics (carbamazepine, diazepam, etc.), antidepressants (imipramine, amitriptyline, etc.), and Chinese herbal medicines or Chinese patent medicines with analgesic and sedative effects;
Expected to receive anti-tumor drugs and treatments during the period from 14 days before randomization to the end of the follow-up period, including but not limited to chemotherapeutic drugs, targeted drugs, and Chinese herbal medicines.
The time between randomization and the last use of diuretics and compound drugs containing diuretic components is shorter than 5 half-lives of the drug or the duration of drug efficacy (whichever is longer);
Laboratory test parameters meet one of the following criteria in the screening period and is confirmed by retests:
White blood cell count < 3.0 x 10^9/L;
Platelet count < 80 x 10^9/L;
Hemoglobin <70 g/L;
Prothrombin time > 1.5 x ULN;
Activated partial thromboplastin time > 1.5 x ULN;
Alanine aminotransferase and/or aspartate aminotransferase > 2 x ULN;
Total bilirubin > 1.5 x ULN;
Blood creatinine > 1.5 x ULN;
Fasting blood glucose ≥ 11.1 mmol/L;
Without oxygen supplement during the screening period, the pulse oxygen saturation is < 92%;
During the screening period, the virological examination for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody is positive;
History of drug abuse, narcotics use and/or alcohol abuse within 3 months before screening. Alcohol abuse is defined as > 2 units of alcohol consumption per day (1 unit = 360 mL of beer containing 5% alcohol, 45 mL of liquor containing 40% alcohol, or 150 mL of wine);
Donated or lost ≥ 400 mL of blood within 3 months before screening;
Participated in any drug clinical trials within 3 months before screening (defined as the administration of the investigational product or placebo);
Women who are pregnant or breastfeeding; fertile women or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
Subjects determined by the investigator to be unsuitable for participating in this clinical study for any other reason.

Trial locations and contacts

1 site in 1 country.

China1 site

Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Two-stage Phase II Study Evaluating the Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

Conditions: Analgesia
Being tested: Experimental: stage I：HSK21542 0.4 μg/kg, Experimental: stage I：HSK21542 1 μg/kg, Experimental: stage I：HSK21542 0.5μg/kg, Experimental: stage I：HSK21542 1μg/kg, Experimental: stage II：HSK21542 0.5μg/kg
Medical subject headings: Agnosia

What participants receive

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

Experimental: stage I：HSK21542 0.4 μg/kgDrug
Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
Experimental: stage I：HSK21542 1 μg/kgDrug
Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
Experimental: stage I：HSK21542 0.5μg/kgDrug
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Experimental: stage I：HSK21542 1μg/kgDrug
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Experimental: stage II：HSK21542 0.5μg/kgDrug
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Experimental: stage II：HSK21542 1μg/kgDrug
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
PlaceboDrug
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations

Study groups in NCT04424251
Study group	Role	What they receive
stage I：HSK21542 0.4 μg/kg	Experimental	Preoperative:0.4 μg/kg Postoperative:0.2 μg/kg； intravenous injection Receives: Drug: Experimental: stage I：HSK21542 0.4 μg/kg
stage I：HSK21542 1 μg/kg	Experimental	Preoperative:1 μg/kg Postoperative:0.5 μg/kg；intravenous injection Receives: Drug: Experimental: stage I：HSK21542 1 μg/kg
stage I：HSK21542 0.5μg/kg	Experimental	Postoperative: 0.5μg/kg；intravenous injection Receives: Drug: Experimental: stage I：HSK21542 0.5μg/kg
stage I：HSK21542 1μg/kg	Experimental	Postoperative: 1μg/kg；intravenous injection Receives: Drug: Experimental: stage I：HSK21542 1μg/kg
stage II：HSK21542 0.5μg/kg	Experimental	Postoperative: 0.5μg/kg；intravenous injection Receives: Drug: Experimental: stage II：HSK21542 0.5μg/kg
stage II：HSK21542 1μg/kg	Experimental	Postoperative: 1μg/kg；intravenous injection Receives: Drug: Experimental: stage II：HSK21542 1μg/kg
Postoperative: Placebo	Placebo comparator	Placebo；intravenous injection Receives: Drug: Placebo

What is being measured

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

Sum of Pain Intensity Differences (SPID)
The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group
Measured: Frome administration until 24 hours after administration

Secondary outcomes (6)

Sum of Pain Intensity Differences (SPID)
The time-weighted sum of pain intensity differences of the rest pain in each group within 0-12 h after the first postoperative dose
Measured: Frome administration until 24 hours after administration
Use of remedial analgesics
Cumulative dose of remedial analgesics (mg of morphine injection) in each group within 0-12 h and 0-24 h after the first postoperative dose, the percentage of subjects in each group who have not used remedial analgesics, and the time to start using remedial analgesics
Measured: Frome administration until 24 hours after administration
Pain Intensity Differences（PID）
The PID at rest at each scoring time point after the first postoperative administration in each group
Measured: Frome administration until 24 hours after administration
The proportion of subjects with a NRS of ≤ 3
The proportion of subjects in each group with a resting pain NRS of ≤ 3 at 12 h and 24 h after the first postoperative dose
Measured: Frome administration until 24 hours after administration
Duration of analgesia
The duration of analgesia after the first postoperative administration in each group
Measured: Frome administration until 24 hours after administration
Satisfaction scores on postoperative analgesia
Subject satisfaction score and investigator satisfaction score on postoperative analgesia at 24 h after the first postoperative administration in each group
Measured: Frome administration until 24 hours after administration

Timeline

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

2 Jul 20205 Jan 2021

First posted9 Jun 2020
Study start2 Jul 2020
Primary completion7 Dec 2020
Study completion5 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnalgesiaStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04424251
Sponsor's protocol ID: HSK21542-201
Status last verified: Aug 2024
First submitted: 3 Jun 2020
Last updated: 26 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhong Y, Wang H, Yan M, Yang M, Zhang J, Nan L, Wang Z, Yang J, Wu J, Guo Q, Hu X, Xu H, Xu Q, Wang D. Efficacy and safety of peripherally-restricted kappa-opioid receptor agonist-HSK21542 for postoperative analgesia in patients undergoing laparoscopic abdominal surgery: a randomized, placebo-controlled phase 2 trial. Front Med (Lausanne). 2025 Jul 24;12:1604790. doi: 10.3389/fmed.2025.1604790. eCollection 2025.
PubMed 40776930

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Two-stage Phase II Study Evaluating the Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia
ClinicalTrials.gov ID: NCT04424251
Acronym / sponsor ID: HSK21542-201
Conditions: Analgesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Jul 2020 (actual)
Primary completion: 7 Dec 2020 (actual)
Study completion: 5 Jan 2021 (actual)
First posted: 9 Jun 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
stage I：HSK21542 0.4 μg/kg	Experimental	Drug: Experimental: stage I：HSK21542 0.4 μg/kgPreoperative:0.4 μg/kg Postoperative:0.2 μg/kg； intravenous injection
stage I：HSK21542 1 μg/kg	Experimental	Drug: Experimental: stage I：HSK21542 1 μg/kgPreoperative:1 μg/kg Postoperative:0.5 μg/kg；intravenous injection
stage I：HSK21542 0.5μg/kg	Experimental	Drug: Experimental: stage I：HSK21542 0.5μg/kgPostoperative: 0.5μg/kg；intravenous injection
stage I：HSK21542 1μg/kg	Experimental	Drug: Experimental: stage I：HSK21542 1μg/kgPostoperative: 1μg/kg；intravenous injection
stage II：HSK21542 0.5μg/kg	Experimental	Drug: Experimental: stage II：HSK21542 0.5μg/kgPostoperative: 0.5μg/kg；intravenous injection
stage II：HSK21542 1μg/kg	Experimental	Drug: Experimental: stage II：HSK21542 1μg/kgPostoperative: 1μg/kg；intravenous injection
Postoperative: Placebo	Placebo comparator	Drug: PlaceboPlacebo；intravenous injection

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 ≤ age ≤ 70 years old, with no gender requirement
American Society of Anesthesiologists (ASA) Class I-II
18 kg/m^2 ≤ BMI ≤ 40 kg/m^2
Subjects undergoing elective laparoscopic surgery under general anesthesia with an expected surgery duration of 1-5 h (inclusive)
Agree to participate in this trial and voluntarily sign the informed consent form;

Key exclusion criteria (35 listed)

History of allergy to opioids, such as urticaria, or allergic to the intraoperative anesthetics prescribed in the protocol;
History or evidence of any one of the following diseases prior to screening:
Any of the following airway management risks during screening:
In receipt of any of the following drugs or therapies during the screening period:
Laboratory test parameters meet one of the following criteria in the screening period and is confirmed by retests:

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
Experimental: stage I：HSK21542 0.4 μg/kgOnce preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations	Drug	stage I：HSK21542 0.4 μg/kg
Experimental: stage I：HSK21542 1 μg/kgOnce preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations	Drug	stage I：HSK21542 1 μg/kg
Experimental: stage I：HSK21542 0.5μg/kgonce each at 0, 8, and 16 h postoperative, for a total of 3 administrations	Drug	stage I：HSK21542 0.5μg/kg
Experimental: stage I：HSK21542 1μg/kgonce each at 0, 8, and 16 h postoperative, for a total of 3 administrations	Drug	stage I：HSK21542 1μg/kg
Experimental: stage II：HSK21542 0.5μg/kgonce each at 0, 8, and 16 h postoperative, for a total of 3 administrations	Drug	stage II：HSK21542 0.5μg/kg
Experimental: stage II：HSK21542 1μg/kgonce each at 0, 8, and 16 h postoperative, for a total of 3 administrations	Drug	stage II：HSK21542 1μg/kg
Placeboonce each at 0, 8, and 16 h postoperative, for a total of 3 administrations	Drug	Postoperative: Placebo

Primary outcome

Sum of Pain Intensity Differences (SPID)
Time frame: Frome administration until 24 hours after administration
The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group

6 secondary outcomes

Sum of Pain Intensity Differences (SPID)
Time frame: Frome administration until 24 hours after administration
Use of remedial analgesics
Time frame: Frome administration until 24 hours after administration
Pain Intensity Differences（PID）
Time frame: Frome administration until 24 hours after administration
The proportion of subjects with a NRS of ≤ 3
Time frame: Frome administration until 24 hours after administration
Duration of analgesia
Time frame: Frome administration until 24 hours after administration
Satisfaction scores on postoperative analgesia
Time frame: Frome administration until 24 hours after administration

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 26 Aug 2024.
Derived from this study: PubMed 40776930Zhong Y, Wang H, Yan M, Yang M, Zhang J, Nan L, Wang Z, Yang J, Wu J, Guo Q, Hu X, Xu H, Xu Q, Wang D. Efficacy and safety of peripherally-restricted kappa-opioid receptor agonist-HSK21542 for postoperative analgesia in patients undergoing laparoscopic abdominal surgery: a randomized, placebo-controlled phase 2 trial. Front Med (Lausanne). 2025 Jul 24;12:1604790. doi: 10.3389/fmed.2025.1604790. eCollection 2025.

Related trials for Analgesia

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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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.

1 site 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 35 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Sum of Pain Intensity Differences (SPID) (time frame: Frome administration until 24 hours after administration). 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 NCT04424251, which also lists 1 linked publication.

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 26 Aug 2024.