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A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

Primary Purpose

Postoperative Pain Of Laparoscopic Surgery

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SHR0410 Injection
SHR0410 Injection
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Of Laparoscopic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
  3. Male or female
  4. Meet the body mass index standard
  5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

  1. Subjects with a history of difficult airway
  2. Subjects with a history of mental illness
  3. Subjects with a history of cognitive impairment epilepsy
  4. Subjects with a history of myocardial infarction or unstable angina pectoris
  5. Subjects with atrioventricular block or cardiac insufficiency
  6. Subjects with a history of ischemic stroke or transient ischemic attack
  7. Subjects with poor blood pressure control after medication
  8. Subject with a history of substance abuse and drug abuse
  9. Abnormal values in liver function
  10. Allergic to drugs that may be used during the study
  11. Pregnant or nursing women
  12. No birth control during the specified period of time
  13. Participated in clinical trials of other drugs (received experimental drugs)
  14. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Treatment group A

    Treatment group B

    Treatment group C

    Arm Description

    SHR0410 Injection（Low Dose）

    SHR0410 Injection（High Dose）

    Placebo for SHR0410 Injection.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less
    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".
    Total consumption of remedial analgesics from 0 to 24 hours
    Participant' Satisfaction Score For Analgesia Treatment
    Investigator Satisfaction Score For Analgesia Treatment
    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.
    Numbers of Participants With Abnormal Vital Signs
    Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.
    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.
    Numbers of Participants With Abnormal Laboratory Values
    Participants with clinically significant lab values will be compared to those receiving placebo comparator.

    Full Information

    First Posted
    June 30, 2022
    Last Updated
    July 12, 2022
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05459220
    Brief Title
    A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
    Official Title
    A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    February 28, 2023 (Anticipated)
    Study Completion Date
    February 28, 2023 (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 and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain Of Laparoscopic Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    SHR0410 injection compared with placebo
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    357 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group A
    Arm Type
    Experimental
    Arm Description
    SHR0410 Injection（Low Dose）
    Arm Title
    Treatment group B
    Arm Type
    Experimental
    Arm Description
    SHR0410 Injection（High Dose）
    Arm Title
    Treatment group C
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for SHR0410 Injection.
    Intervention Type
    Drug
    Intervention Name(s)
    SHR0410 Injection
    Intervention Description
    SHR0410 Injection（Low Dose）
    Intervention Type
    Drug
    Intervention Name(s)
    SHR0410 Injection
    Intervention Description
    SHR0410 Injection（High Dose）
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo for SHR0410 Injection.
    Primary Outcome Measure Information:
    Title
    Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
    Description
    Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
    Time Frame
    0 to 24 hours
    Secondary Outcome Measure Information:
    Title
    Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)
    Description
    Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
    Time Frame
    0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
    Title
    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
    Title
    Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours
    Description
    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".
    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
    Title
    Total consumption of remedial analgesics from 0 to 24 hours
    Time Frame
    24-hours
    Title
    Participant' Satisfaction Score For Analgesia Treatment
    Time Frame
    24-hours
    Title
    Investigator Satisfaction Score For Analgesia Treatment
    Time Frame
    24-hours
    Title
    Numbers of Participants With Abnormal Vital Signs
    Description
    Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.
    Time Frame
    Day 3 or Day 4
    Title
    Numbers of Participants With Abnormal Vital Signs
    Description
    Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.
    Time Frame
    Day 3 or Day 4
    Title
    Numbers of Participants With Abnormal Vital Signs
    Description
    Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.
    Time Frame
    Day 3 or Day 4
    Title
    Numbers of Participants With Abnormal Laboratory Values
    Description
    Participants with clinically significant lab values will be compared to those receiving placebo comparator.
    Time Frame
    Day 3 or Day 4

    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 endoscopic surgery of the lower abdominal Male or female Meet the body mass index standard Conform to the ASA Physical Status Classification Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qin Liu
    Phone
    +0518-82342973
    Email
    qin.liu@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

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