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HSK16149 for Perioperative Analgesia in Orthopedic Surgery

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK16149 capsule
Placebo
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female between the ages of 18 and 75 years (included); Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours; 18kg/m^2≤BMI≤30 kg/m^2; American Society of Anesthesiologists (ASA) grade I and II; Exclusion Criteria: Any of the following medical histories or conditions prior to screening: Long history of chronic pain; history of severe cardiovascular or respiratory disease; history of neurological or psychiatric disorders; history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system; major surgery within 3 months; patients with high bleeding risk; history of renal disease treated with dialysis within 28 days before surgery; have active infection within the past 2 weeks; Use of any of the following medications or treatments: opioid analgesics for more than 10 consecutive days within 3 months prior to screening; other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label); Abnormal laboratory tests during screening: Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening; A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening; Participated in another clinical trial and received IMP within 30 days prior to screening; Pregnant or lactating women; Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;

Sites / Locations

  • Dongguan People's Hospital
  • Foshan Fuxing Chancheng Hospital
  • The First Affiliated Hospital of Jinan University
  • Affiliated Hospital of Guizhou Medical University
  • Beijing Jishuitan Hospital Guizhou Hospital
  • Zunyi University Affiliated Hospital
  • Henan Provincial People's Hospital
  • People's Hospital of Wuhan University
  • Wuhan Central Hospital
  • Xiangya Third Hospital of Central South University
  • The First Affiliated Hospital of South China University
  • Lianyungang First People's Hospital
  • Nanjing First Hospital
  • Chengdu Second People's Hospital
  • Chengdu Third People's Hospital
  • Sichuan Provincial People's Hospital
  • Guangyuan First People's Hospital
  • Mianyang Central Hospital
  • Yibin Second People's Hospital
  • The First People's Hospital of Yunnan Province
  • Sino-Japanese Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Preoperative administration of HSK16149 40mg

Preoperative administration of HSK16149 60mg

Preoperative and postoperative administration of HSK16149 40mg

Preoperative and postoperative administration of HSK16149 60mg

placebo

Arm Description

HSK16149 40mg will be administered the night before and 2h before surgery

HSK16149 60mg will be administered the night before and 2h before surgery

HSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery

HSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery

The placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery

Outcomes

Primary Outcome Measures

Morphine Consumption
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.

Secondary Outcome Measures

NRS at rest and during exercise
NRS:0 (no pain) to 10 (worst possible pain)
Time of first rescue analgesia with morphine after surgery
Incidence of adverse reactions associated with morphine
The frequency of rescue analgesia with morphine
The total number of PCA presses and the number of effective PCA presses
Daily Sleep Interference Scale (DSIS)
Subjects review their sleep status during the past 12 hours at 8:00 a.m. on the day of surgery. DSIS: 0 (not affecting sleep) to 10 (unable to sleep)
Subjects analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Investigators analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs)(including QT Interval,QTc Interval and PR Interval), and vital signs.

Full Information

First Posted
March 5, 2023
Last Updated
August 17, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06007066
Brief Title
HSK16149 for Perioperative Analgesia in Orthopedic Surgery
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.
Detailed Description
This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h. Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period. Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. After the treatment period, the subjects will be followed up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative administration of HSK16149 40mg
Arm Type
Experimental
Arm Description
HSK16149 40mg will be administered the night before and 2h before surgery
Arm Title
Preoperative administration of HSK16149 60mg
Arm Type
Experimental
Arm Description
HSK16149 60mg will be administered the night before and 2h before surgery
Arm Title
Preoperative and postoperative administration of HSK16149 40mg
Arm Type
Experimental
Arm Description
HSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
Arm Title
Preoperative and postoperative administration of HSK16149 60mg
Arm Type
Experimental
Arm Description
HSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
Intervention Type
Drug
Intervention Name(s)
HSK16149 capsule
Other Intervention Name(s)
HSK16149
Intervention Description
Subjects will be given 40mg or 60mg of HSK16149 orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
HSK16149 placebo
Intervention Description
Subjects will be given HSK16149 placebo orally.
Primary Outcome Measure Information:
Title
Morphine Consumption
Description
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.
Time Frame
Participants received PCA pump, an average of 24 hours after surgery
Secondary Outcome Measure Information:
Title
NRS at rest and during exercise
Description
NRS:0 (no pain) to 10 (worst possible pain)
Time Frame
1, 2, 6, 12, 18, and 24 hours after surgery
Title
Time of first rescue analgesia with morphine after surgery
Time Frame
Within 24 hours after surgery
Title
Incidence of adverse reactions associated with morphine
Time Frame
Within 24 hours after surgery
Title
The frequency of rescue analgesia with morphine
Time Frame
Within 24 hours after surgery
Title
The total number of PCA presses and the number of effective PCA presses
Time Frame
Within 24 hours after surgery
Title
Daily Sleep Interference Scale (DSIS)
Description
Subjects review their sleep status during the past 12 hours at 8:00 a.m. on the day of surgery. DSIS: 0 (not affecting sleep) to 10 (unable to sleep)
Time Frame
Within 24 hours after surgery
Title
Subjects analgesic satisfaction score
Description
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Time Frame
Within 24 hours after surgery
Title
Investigators analgesic satisfaction score
Description
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Time Frame
Within 24 hours after surgery
Title
Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
Description
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs)(including QT Interval,QTc Interval and PR Interval), and vital signs.
Time Frame
From enrollment to 72 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between the ages of 18 and 75 years (included); Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours; 18kg/m^2≤BMI≤30 kg/m^2; American Society of Anesthesiologists (ASA) grade I and II; Exclusion Criteria: Any of the following medical histories or conditions prior to screening: Long history of chronic pain; history of severe cardiovascular or respiratory disease; history of neurological or psychiatric disorders; history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system; major surgery within 3 months; patients with high bleeding risk; history of renal disease treated with dialysis within 28 days before surgery; have active infection within the past 2 weeks; Use of any of the following medications or treatments: opioid analgesics for more than 10 consecutive days within 3 months prior to screening; other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label); Abnormal laboratory tests during screening: Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening; A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening; Participated in another clinical trial and received IMP within 30 days prior to screening; Pregnant or lactating women; Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;
Facility Information:
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
Country
China
Facility Name
Foshan Fuxing Chancheng Hospital
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Beijing Jishuitan Hospital Guizhou Hospital
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Zunyi University Affiliated Hospital
City
Zunyi
State/Province
Guizhou
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
People's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan Central Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Third Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First Affiliated Hospital of South China University
City
Hengyang
State/Province
Hunan
Country
China
Facility Name
Lianyungang First People's Hospital
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Chengdu Second People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Chengdu Third People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Guangyuan First People's Hospital
City
Guangyuan
State/Province
Sichuan
Country
China
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
Country
China
Facility Name
Yibin Second People's Hospital
City
Yibin
State/Province
Sichuan
Country
China
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Sino-Japanese Friendship Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HSK16149 for Perioperative Analgesia in Orthopedic Surgery

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