Back to resultsA Trial of SHR0410 Injection in Postsurgical Pain Management
Primary Purpose
Postsurgical Pain
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR0410 Injection
Placebo for SHR0410 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Postsurgical Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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；
- 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.
Sites / Locations
- Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SHR0410 Injection High dose
SHR0410 Injection Low dose
Placebo for SHR0410 Injection
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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
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.
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.
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
Full Information
NCT ID
NCT05394402
First Posted
May 24, 2022
Last Updated
August 19, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05394402
Brief Title
A Trial of SHR0410 Injection in Postsurgical Pain Management
Official Title
A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 3, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR0410 Injection compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR0410 Injection High dose
Arm Type
Experimental
Arm Title
SHR0410 Injection Low dose
Arm Type
Experimental
Arm Title
Placebo for SHR0410 Injection
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR0410 Injection
Intervention Description
SHR0410 Injection
Intervention Type
Drug
Intervention Name(s)
Placebo for SHR0410 Injection
Intervention Description
SHR0410 Injection blank preparation
Primary Outcome Measure Information:
Title
Usage of Morphine, Post Surgery
Description
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration
Time Frame
0 hour to 48 hours after IP administration
Secondary Outcome Measure Information:
Title
Usage of Morphine, Post Surgery at other intervals
Description
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.
Time Frame
0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration
Title
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition
Description
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.
Time Frame
48-hours
Title
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition
Description
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.
Time Frame
48-hours
Title
Time to First Dose of Rescue Analgesia
Description
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.
Time Frame
0 hour to 48 hours after IP administration
Title
Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject
Description
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
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
Title
Total press times of PCA pump and effective press times of PCA pump
Description
Read and record the press times and effective press times from PCA
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
Title
Proportion of subjects who did not receive Rescue Analgesia
Description
Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of 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
Title
Participant ' satisfaction score for analgesia treatment
Description
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.
Time Frame
48-hours
Title
Investigator satisfaction score for analgesia treatment
Description
Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied
Time Frame
48-hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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；
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Lin, M.M
Phone
+0518-82342973
Email
Qin.liu@hengrui.com
Facility Information:
Facility Name
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Chen, Doctor
Phone
027-85351618
Email
Xiangdongchen2013@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of SHR0410 Injection in Postsurgical Pain Management
We'll reach out to this number within 24 hrs