Postoperative Pain ManagementPhase 2NCT07442877
A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
A Phase 2 study testing HSK21542 dose level 1, HSK21542 dose level 2 and morphine in people with Postoperative Pain Management, run by Haisco Pharmaceutical Group Co., Ltd. at 27 sites in China.
Trial summary
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- HSK21542 dose level 1, HSK21542 dose level 2 and morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 27 sitesChina
- Study dates
- 13 Sep 2024to 24 Jan 2025
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤74 years old, regardless of gender;
- 18 kg/m2≤BMI≤32 kg/m2, meet the weight range specified in the protocol;
- American Society of Anesthesiologists (ASA) grade 1-3;
- Accept hip replacement under general anesthesia;
- Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
- Fully understand and voluntarily participate this trial, and sign the informed consent form;
Who cannot join
- Patients with allergy to opioids or any component of the trial drug;
- Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
- Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety;
- Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
- Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
- Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
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- A history of drug, drug, and/or alcohol abuse
- Participate in any clinical trail within 30 days;
- Pregnant or lactating female subjects;
- Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.
- Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
Cangzhou, Hebei
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Ganzhou People's Hospital
Ganzhou, Jiangxi
The Third Affiliated Hospital, Southern Medical University
Guangzhou, Guangdong
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui
Huai'an Second People's Hospital
Huaian, Jiangsu
Huzhou Central Hospital
Huzhou, Zhejiang
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong
Jinhua Central Hospital
Jinhua, Zhejiang
Liuzhou People's Hospital
Liuzhou, Guangxi
Mianyang Central Hospital
Mianyang, Sichuan
Mianyang Orthopedic Hospital
Mianyang, Sichuan
Nanjing First Hospital
Nanjing, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
Huashan Hospital, Fudan University
Shanghai
Shenzhen Second People's Hospital
Shenzhen
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Suining Central Hospital
Suining, Sichuan
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Wuxi People's Hospital
Wuxi, Jiangsu
Yichang Central People's Hospital (Wujia Campus)
Yichang, Hubei
Yichang Central People's Hospital (Xiling Campus)
Yichang, Hubei
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
- Conditions
- Postoperative Pain Management
- Being tested
- HSK21542 dose level 1, HSK21542 dose level 2, Placebo, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542 dose level 1Drug
Patients administrated with HSK21542 dose level 1
HSK21542 dose level 2Drug
Patients administrated with HSK21542 dose level 2
PlaceboDrug
Patients administrated with placebo
morphineDrug
Patients administrated with morphine
| Study group | Role | What they receive |
|---|---|---|
| HSK21542 dose level 1 | Experimental | Patients administrated with HSK21542 dose level 1 Receives: Drug: HSK21542 dose level 1 |
| HSK21542 dose level 2 | Experimental | Patients administrated with HSK21542 dose level 2 Receives: Drug: HSK21542 dose level 2 |
| Placebo control | Placebo comparator | Patients administrated with placebo Receives: Drug: Placebo |
| Actice control | Active comparator | Patients administrated with morphine Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences (SPID)
Sum of Pain Intensity Differences (SPID) of each group
Measured: 48 hours
Secondary outcomes (4)
Sum of Pain Intensity Differences (SPID) in other time frame
Sum of Pain Intensity Differences (SPID) in other time frame
Measured: 0-8 hours, 0-24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
Number of times rescue analgesic medications were administered.
Measured: 48 hours
Total morphine consumption
Total morphine consumption of each group
Measured: 48 hours
Proportion of subjects experiencing nausea and/or vomit
Proportion of subjects experiencing nausea and/or vomit of each group
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start13 Sep 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442877
- Sponsor's protocol ID
- HSK21542-209
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07442877
- Acronym / sponsor ID
- HSK21542-209
- Conditions
- Postoperative Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 2 Mar 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.
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK21542 dose level 1 | Experimental | Drug: HSK21542 dose level 1Patients administrated with HSK21542 dose level 1 |
| HSK21542 dose level 2 | Experimental | Drug: HSK21542 dose level 2Patients administrated with HSK21542 dose level 2 |
| Placebo control | Placebo comparator | Drug: PlaceboPatients administrated with placebo |
| Actice control | Active comparator | Drug: morphinePatients administrated with morphine |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old ≤ age ≤74 years old, regardless of gender;
- 18 kg/m2≤BMI≤32 kg/m2, meet the weight range specified in the protocol;
- American Society of Anesthesiologists (ASA) grade 1-3;
- Accept hip replacement under general anesthesia;
- Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
Key exclusion criteria (11 listed)
- Patients with allergy to opioids or any component of the trial drug;
- Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
- Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety;
- Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
- Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
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 |
|---|---|---|
| HSK21542 dose level 1Patients administrated with HSK21542 dose level 1 | Drug | HSK21542 dose level 1 |
| HSK21542 dose level 2Patients administrated with HSK21542 dose level 2 | Drug | HSK21542 dose level 2 |
| PlaceboPatients administrated with placebo | Drug | Placebo control |
| morphinePatients administrated with morphine | Drug | Actice control |
Primary outcome
Sum of Pain Intensity Differences (SPID)
Time frame: 48 hours
Sum of Pain Intensity Differences (SPID) of each group
4 secondary outcomes
Sum of Pain Intensity Differences (SPID) in other time frame
Time frame: 0-8 hours, 0-24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
Time frame: 48 hours
Total morphine consumption
Time frame: 48 hours
Proportion of subjects experiencing nausea and/or vomit
Time frame: 48 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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK21542 dose level 1, HSK21542 dose level 2 and morphine in people with Postoperative Pain Management, run by Haisco Pharmaceutical Group Co., Ltd. at 27 sites in China.
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 6 inclusion and 11 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.