Postoperative Pain Of Laparoscopic SurgeryPhase 3NCT05459220
A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
A Phase 3 study testing SHR0410 Injection in people with Postoperative Pain Of Laparoscopic Surgery, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Of Laparoscopic Surgery
- 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
- 357 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to 28 Feb 2023
- Phase
- Phase 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 endoscopic surgery of the lower abdominal
- Male or female
- Meet the body mass index standard
- Conform to the ASA Physical Status Classification
Who cannot join
- Subjects with a history of difficult airway
- Subjects with a history of mental illness
- Subjects with a history of cognitive impairment epilepsy
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
Show all 14Show fewer
- Subjects with poor blood pressure control after medication
- Subject with a history of substance abuse and drug abuse
- Abnormal values in liver function
- Allergic to drugs that may be used during the study
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery
- Being tested
- SHR0410 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0410 InjectionDrug
SHR0410 Injection（Low Dose）
SHR0410 InjectionDrug
SHR0410 Injection（High Dose）
PlaceboDrug
Placebo for SHR0410 Injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR0410 Injection（Low Dose） Receives: Drug: SHR0410 Injection |
| Treatment group B | Experimental | SHR0410 Injection（High Dose） Receives: Drug: SHR0410 Injection |
| Treatment group C | Placebo comparator | Placebo for SHR0410 Injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
Measured: 0 to 24 hours
Secondary outcomes (10)
Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)
Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
Measured: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less
Measured: 0 to 24 hours
Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours
Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief".
Measured: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
Total consumption of remedial analgesics from 0 to 24 hours
Measured: 24-hours
Participant' Satisfaction Score For Analgesia Treatment
Measured: 24-hours
Investigator Satisfaction Score For Analgesia Treatment
Measured: 24-hours
Numbers of Participants With Abnormal Vital Signs
Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.
Measured: Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.
Measured: Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.
Measured: Day 3 or Day 4
Numbers of Participants With Abnormal Laboratory Values
Participants with clinically significant lab values will be compared to those receiving placebo comparator.
Measured: Day 3 or Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study startJul 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Of Laparoscopic SurgeryStudies 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 3
- 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
- 357 participants (estimated)
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
- NCT05459220
- Sponsor's protocol ID
- SHR0410-302
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05459220
- Acronym / sponsor ID
- SHR0410-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 14 Jul 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 and safety of SHR0410 injection for the treatment of pain after laparoscopic 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 |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR0410 InjectionSHR0410 Injection（Low Dose） |
| Treatment group B | Experimental | Drug: SHR0410 InjectionSHR0410 Injection（High Dose） |
| Treatment group C | Placebo comparator | Drug: PlaceboPlacebo 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 (5 listed)
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
- 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 difficult airway
- Subjects with a history of mental illness
- Subjects with a history of cognitive impairment epilepsy
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
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（Low Dose） | Drug | Treatment group A |
| SHR0410 InjectionSHR0410 Injection（High Dose） | Drug | Treatment group B |
| PlaceboPlacebo for SHR0410 Injection. | Drug | Treatment group C |
Primary outcome
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
Time frame: 0 to 24 hours
Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
10 secondary outcomes
Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)
Time frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less
Time frame: 0 to 24 hours
Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours
Time frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
Total consumption of remedial analgesics from 0 to 24 hours
Time frame: 24-hours
Participant' Satisfaction Score For Analgesia Treatment
Time frame: 24-hours
Investigator Satisfaction Score For Analgesia Treatment
Time frame: 24-hours
Numbers of Participants With Abnormal Vital Signs
Time frame: Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Time frame: Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Time frame: Day 3 or Day 4
Numbers of Participants With Abnormal Laboratory Values
Time frame: Day 3 or Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR0410 Injection in people with Postoperative Pain Of Laparoscopic Surgery, run by Jiangsu HengRui Medicine 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 5 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: status not confirmed, as of the sponsor's last update on 14 Jul 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Liu (+0518-82342973, qin.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24) (time frame: 0 to 24 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 14 Jul 2022.