Postsurgical PainPhase 2NCT05394402
A Trial of SHR0410 Injection in Postsurgical Pain Management
A Phase 2 study testing SHR0410 Injection in people with Postsurgical Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain
- What is being tested?
- SHR0410 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2022to 31 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent；
- Subjects requiring elective general anesthesia orthopedic surgery；
- Male or female；
- Meet the body mass index standard；
- Conform to the ASA Physical Status Classification；
- Negative pregnancy test.
Who cannot join
- Subjects with a history of myocardial infarction or unstable angina pectoris；
- Subjects with atrioventricular block or cardiac insufficiency；
- Subjects with a history of malignancy ；
- Subjects with a history of stroke；
- Subjects with a history of mental illness；
- Subjects with a history of difficult airway；
Show all 14Show fewer
- Random blood glucose ≥11.1mmol/L；
- Subjects with poor blood pressure control；
- Abnormal values in liver or renal function；
- Subject with a history of substance abuse and drug abuse；
- Allergic to drugs that may be used during the study；
- Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
- Participated in clinical trials of other drugs (received experimental drugs)；
- Other circumstances that the investigator judged inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.
- Conditions
- Postsurgical Pain
- Being tested
- SHR0410 Injection, Placebo for SHR0410 Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0410 InjectionDrug
SHR0410 Injection
Placebo for SHR0410 InjectionDrug
SHR0410 Injection blank preparation
| Study group | Role | What they receive |
|---|---|---|
| SHR0410 Injection High dose | Experimental | Not described Receives: Drug: SHR0410 Injection |
| SHR0410 Injection Low dose | Experimental | Not described Receives: Drug: SHR0410 Injection |
| Placebo for SHR0410 Injection | Placebo comparator | Not described Receives: Drug: Placebo for SHR0410 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Morphine, Post Surgery
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration
Measured: 0 hour to 48 hours after IP administration
Secondary outcomes (9)
Usage of Morphine, Post Surgery at other intervals
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-24 hours after IP administration.Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 4-48 hours after IP administration.
Measured: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition
Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS.
Measured: 48-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition
Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS.
Measured: 48-hours
Time to First Dose of Rescue Analgesia
Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Measured: 0 hour to 48 hours after IP administration
Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
Measured: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Total press times of PCA pump and effective press times of PCA pump
Read and record the press times and effective press times from PCA
Measured: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Proportion of subjects who did not receive Rescue Analgesia
Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Measured: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Participant ' satisfaction score for analgesia treatment
Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.
Measured: 48-hours
Investigator satisfaction score for analgesia treatment
Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied
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 May 2022
- Study start9 Aug 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Adjustment of R\&D strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical PainStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Model description
- SHR0410 Injection compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394402
- Sponsor's protocol ID
- SHR0410-202
- Status last verified
- May 2025
- First submitted
- 24 May 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT05394402
- Acronym / sponsor ID
- SHR0410-202
- Conditions
- Postsurgical Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of R\&D strategy
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 May 2022 (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.
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- SHR0410 Injection compared with placebo
| Arm | Type | Receives |
|---|---|---|
| SHR0410 Injection High dose | Experimental | Drug: SHR0410 Injection |
| SHR0410 Injection Low dose | Experimental | Drug: SHR0410 Injection |
| Placebo for SHR0410 Injection | Placebo comparator | Drug: Placebo for SHR0410 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to provide a written informed consent；
- Subjects requiring elective general anesthesia orthopedic surgery；
- Male or female；
- Meet the body mass index standard；
- Conform to the ASA Physical Status Classification；
Key exclusion criteria (14 listed)
- Subjects with a history of myocardial infarction or unstable angina pectoris；
- Subjects with atrioventricular block or cardiac insufficiency；
- Subjects with a history of malignancy ；
- Subjects with a history of stroke；
- Subjects with a history of mental illness；
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 |
|---|---|---|
| SHR0410 InjectionSHR0410 Injection | Drug | SHR0410 Injection High dose, SHR0410 Injection Low dose |
| Placebo for SHR0410 InjectionSHR0410 Injection blank preparation | Drug | Placebo for SHR0410 Injection |
Primary outcome
Usage of Morphine, Post Surgery
Time frame: 0 hour to 48 hours after IP administration
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration
9 secondary outcomes
Usage of Morphine, Post Surgery at other intervals
Time frame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition
Time frame: 48-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition
Time frame: 48-hours
Time to First Dose of Rescue Analgesia
Time frame: 0 hour to 48 hours after IP administration
Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject
Time frame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Total press times of PCA pump and effective press times of PCA pump
Time frame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Proportion of subjects who did not receive Rescue Analgesia
Time frame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Participant ' satisfaction score for analgesia treatment
Time frame: 48-hours
Investigator satisfaction score for analgesia treatment
Time frame: 48-hours
Results and safety
The study was stopped early (reason given: Adjustment of R\&D strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 2 study testing SHR0410 Injection in people with Postsurgical Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 14 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: stopped early, as of the sponsor's last update on 22 Jun 2025. 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 was stopped early (reason given: Adjustment of R\&D strategy). Results are not available in the source record.
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?
Usage of Morphine, Post Surgery (time frame: 0 hour to 48 hours after IP administration). 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 22 Jun 2025.