PainPhase 3NCT04852003
A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
A Phase 3 study testing SHR0410 Injection and Morphine in people with Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- SHR0410 Injection and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2021to 22 Jul 2021
- 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 to 65 years
- 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 15Show fewer
- Subjects with poor blood pressure control after medication
- Subject with a history of substance abuse and drug abuse
- Abnormal values in liver function
- Subjects with an oxygen saturation below 90% on room air
- 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
1 site in 1 country.
About this study
Official title: A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0410 InjectionDrug
SHR0410 Injection
PlaceboDrug
Placebo for SHR0410 Injection
MorphineDrug
Morphine
| Study group | Role | What they receive |
|---|---|---|
| SHR0410 Injection | Experimental | Not described Receives: Drug: SHR0410 Injection |
| Placebo for SHR0410 Injection | 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.
The area under the curve of pain intensity over 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, administered over 24 hours.
Measured: 24-hours
Secondary outcomes (6)
Total consumption of remedial analgesics from 0h to 24h
Total consumption of IV morphine
Measured: 24-hours
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: 24-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: 24-hours
Frequency and severity of adverse events
Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator.
Measured: Day 4（or early termination on Day 3）
Safety as assessed by vital signs
Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.
Measured: Day 4（or early termination on Day 3）
Safety as assessed by laboratory evaluations
Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.
Measured: Day 4（or early termination on Day 3）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start13 May 2021
- Primary completion26 Jun 2021
- Study completion22 Jul 2021
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR0410 injection compared with placebo and morphine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 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
- NCT04852003
- Sponsor's protocol ID
- SHR0410-301
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
- ClinicalTrials.gov ID
- NCT04852003
- Acronym / sponsor ID
- SHR0410-301
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 21 Apr 2021 (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 endoscopic surgery of the lower abdominal.
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 and morphine
| Arm | Type | Receives |
|---|---|---|
| SHR0410 Injection | Experimental | Drug: SHR0410 Injection |
| Placebo for SHR0410 Injection | Placebo comparator | Drug: Placebo |
| Morphine | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 to 65 years
- 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 (15 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 | Drug | SHR0410 Injection |
| PlaceboPlacebo for SHR0410 Injection | Drug | Placebo for SHR0410 Injection |
| MorphineMorphine | Drug | Morphine |
Primary outcome
The area under the curve of pain intensity over 24 hours
Time frame: 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, administered over 24 hours.
6 secondary outcomes
Total consumption of remedial analgesics from 0h to 24h
Time frame: 24-hours
Participant ' satisfaction score for analgesia treatment
Time frame: 24-hours
Investigator satisfaction score for analgesia treatment
Time frame: 24-hours
Frequency and severity of adverse events
Time frame: Day 4（or early termination on Day 3）
Safety as assessed by vital signs
Time frame: Day 4（or early termination on Day 3）
Safety as assessed by laboratory evaluations
Time frame: Day 4（or early termination on Day 3）
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 10 Feb 2022.
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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 3 study testing SHR0410 Injection 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 5 inclusion and 15 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 10 Feb 2022. 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 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 area under the curve of pain intensity over 24 hours (time frame: 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 10 Feb 2022.