- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05470049
A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.
July 20, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase II, Randomized, Double-Blind Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.
The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qin Liu
- Phone Number: +0518-82342973
- Email: qin.liu@hengrui.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia abdominal surgery
- Conform to the ASA Physical Status Classification
Exclusion Criteria:
- 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
- Random blood glucose ≥11.1mmol/L
- Subjects with abnormal liver function
- allergies to opioids and other medications that may be used during the trial
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group A: SHR8554 Injection and SHR0410 Injection
|
Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose
Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose
|
Experimental: Treatment group B: SHR8554 Injection and SHR0410 Injection
|
Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose
Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose
|
Placebo Comparator: Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection
|
Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Sum of Pain Intensity Differences in Pain Score Over 24 Hours
Time Frame: 24-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 24 hours.
Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
|
24-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Sum of Pain Intensity Differences in Pain Score Over 6、12、12-24 Hours
Time Frame: 6-hours、12-hours、12-24 hours
|
time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、12-24 hours) to yield values on the 0-10 NPRS.
|
6-hours、12-hours、12-24 hours
|
Time of first use of remedial analgesic medication
Time Frame: 24-hours
|
The first time to use remedial analgesic medication for injection
|
24-hours
|
Cumulative use of remedial analgesics from 0h to 24h
Time Frame: 24-hours
|
Cumulative use of remedial analgesic medication
|
24-hours
|
Participant ' satisfaction score for analgesia treatment
Time Frame: 24-hours
|
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.
|
24-hours
|
Investigator satisfaction score for analgesia treatment
Time Frame: 24-hours
|
Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.
|
24-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
November 30, 2022
Study Registration Dates
First Submitted
July 20, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- SHR8554/SHR0410-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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