PainPhase 2/3NCT05375305
A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
A Phase 2/3 study testing SHR8554 Injection, Saline Solution and Morphine in people with Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- SHR8554 Injection, Saline Solution and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2022to 19 Oct 2023
- Phase
- Phase 2/3
- 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
- Conform to the ASA Physical Status Classification
Who cannot join
- Subjects with a history of difficult airway
- Subjects with a history of reflux esophagitis
- Subjects with a history of mental illness
- Subjects with poor blood pressure control
- Transcutaneous oxygen saturation (SpO2) <90%
- Random blood glucose ≥11.1mmol/L
- Subjects with abnormal liver function
- allergies to opioids and other medications that may be used during the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8554 InjectionDrug
SHR8554 Injection; high dose
SHR8554 InjectionDrug
SHR8554 Injection; low dose
Saline SolutionDrug
Saline Solution
MorphineDrug
Morphine
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A：SHR8554 Injection | Experimental | Not described Receives: Drug: SHR8554 Injection |
| Treatment group B：SHR8554 Injection | Experimental | Not described Receives: Drug: SHR8554 Injection |
| Treatment group C：Saline Solution | Placebo comparator | Not described Receives: Drug: Saline Solution |
| Treatment group D：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.
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), 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 NPRS.
Measured: 48-hours
Secondary outcomes (5)
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition
Measured: 48-hours
Time of first use of remedial analgesic medication
Measured: 48-hours
Cumulative use of remedial analgesics from 0h to 48h
Measured: 48-hours
Participant ' satisfaction score for analgesia treatment
Measured: 48-hours
Investigator satisfaction score for analgesia treatment
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 posted16 May 2022
- Study start11 May 2022
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 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
- NCT05375305
- Sponsor's protocol ID
- SHR8554-203
- Status last verified
- Oct 2023
- First submitted
- 11 May 2022
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05375305
- Acronym / sponsor ID
- SHR8554-203
- Conditions
- Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 16 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 primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment group A：SHR8554 Injection | Experimental | Drug: SHR8554 Injection |
| Treatment group B：SHR8554 Injection | Experimental | Drug: SHR8554 Injection |
| Treatment group C：Saline Solution | Placebo comparator | Drug: Saline Solution |
| Treatment group D：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 (3 listed)
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia orthopedic surgery
- Conform to the ASA Physical Status Classification
Key exclusion criteria (8 listed)
- Subjects with a history of difficult airway
- Subjects with a history of reflux esophagitis
- Subjects with a history of mental illness
- Subjects with poor blood pressure control
- Transcutaneous oxygen saturation (SpO2) <90%
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 |
|---|---|---|
| SHR8554 InjectionSHR8554 Injection; high dose | Drug | Treatment group A：SHR8554 Injection |
| SHR8554 InjectionSHR8554 Injection; low dose | Drug | Treatment group B：SHR8554 Injection |
| Saline SolutionSaline Solution | Drug | Treatment group C：Saline Solution |
| MorphineMorphine | Drug | Treatment group D：Morphine |
Primary outcome
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
Time frame: 48-hours
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), 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 NPRS.
5 secondary outcomes
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition
Time frame: 48-hours
Time of first use of remedial analgesic medication
Time frame: 48-hours
Cumulative use of remedial analgesics from 0h to 48h
Time frame: 48-hours
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 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 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 2/3 study testing SHR8554 Injection, Saline Solution and Morphine in people with 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 3 inclusion and 8 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 Dec 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state (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 26 Dec 2023.