Pain After SurgeryPhase 2NCT07551739
A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
A Phase 2 study testing HSK55718 dose level 1, HSK55718 dose level 2 and HSK55718 dose level 3 in people with Pain After Surgery, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain After Surgery
- What is being tested?
- HSK55718 dose level 1, HSK55718 dose level 2 and HSK55718 dose level 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery 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
- A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
- Clinically significant abnormalities in laboratory tests during the screening period.
- A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
- Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
- A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
- Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.
- Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.
- Conditions
- Pain After Surgery
- Being tested
- HSK55718 dose level 1, HSK55718 dose level 2, HSK55718 dose level 3, placebo, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK55718 dose level 1Drug
Patients administrated with HSK55718 at dose level 1
HSK55718 dose level 2Drug
Patients administrated with HSK55718 at dose level 2
HSK55718 dose level 3Drug
Patients administrated with HSK55718 at dose level 3
placeboDrug
Patients administrated with placebo
morphineDrug
Patients administrated with morphine
| Study group | Role | What they receive |
|---|---|---|
| HSK55718 dose level1 | Experimental | Not described Receives: Drug: HSK55718 dose level 1 |
| HSK55718 dose level 2 | Experimental | Not described Receives: Drug: HSK55718 dose level 2 |
| HSK55718 dose level 3 | Experimental | Not described Receives: Drug: HSK55718 dose level 3 |
| Placebo control | Placebo comparator | Not described Receives: Drug: placebo |
| morphine | Active comparator | Not described 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)
Measured: 48hours
Secondary outcomes (4)
Sum of Pain Intensity Differences (SPID) in other time frame
Measured: 0-12 hours, 12-24 hours, 24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
Measured: 48 hours
Time to Pain Relief
Measured: 0-48 hours
Postoperative Analgesia Satisfaction Score
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 posted27 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After SurgeryStudies 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
- 200 participants (estimated)
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
- NCT07551739
- Sponsor's protocol ID
- HSK55718-202
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07551739
- Acronym / sponsor ID
- HSK55718-202
- Conditions
- Pain After Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Apr 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. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 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
- 5
| Arm | Type | Receives |
|---|---|---|
| HSK55718 dose level1 | Experimental | Drug: HSK55718 dose level 1 |
| HSK55718 dose level 2 | Experimental | Drug: HSK55718 dose level 2 |
| HSK55718 dose level 3 | Experimental | Drug: HSK55718 dose level 3 |
| Placebo control | Placebo comparator | Drug: placebo |
| morphine | Active comparator | Drug: morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery 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;
Key exclusion criteria (7 listed)
- A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
- Clinically significant abnormalities in laboratory tests during the screening period.
- A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
- Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
- A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
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 |
|---|---|---|
| HSK55718 dose level 1Patients administrated with HSK55718 at dose level 1 | Drug | HSK55718 dose level1 |
| HSK55718 dose level 2Patients administrated with HSK55718 at dose level 2 | Drug | HSK55718 dose level 2 |
| HSK55718 dose level 3Patients administrated with HSK55718 at dose level 3 | Drug | HSK55718 dose level 3 |
| placeboPatients administrated with placebo | Drug | Placebo control |
| morphinePatients administrated with morphine | Drug | morphine |
Primary outcome
Sum of Pain Intensity Differences (SPID)
Time frame: 48hours
4 secondary outcomes
Sum of Pain Intensity Differences (SPID) in other time frame
Time frame: 0-12 hours, 12-24 hours, 24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
Time frame: 48 hours
Time to Pain Relief
Time frame: 0-48 hours
Postoperative Analgesia Satisfaction Score
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK55718 dose level 1, HSK55718 dose level 2 and HSK55718 dose level 3 in people with Pain After Surgery, run by Haisco Pharmaceutical Group Co., Ltd..
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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongrui Wang (028-67258779, wangyr@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Pain Intensity Differences (SPID) (time frame: 48hours). 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 27 Apr 2026.