HSK16149 for Perioperative Analgesia in Orthopedic Surgery

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06007066
• Other study ID #: HSK16149-204
• Status: Completed
• Phase: Phase 2
• Start date: March 8, 2023
• Est. completion date: July 5, 2023

Study information

• Verified date: August 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: July 5, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female between the ages of 18 and 75 years (included);

2. Elective orthopedic surgery under general anesthesia, expected operation time =4 hours and postoperative morphine analgesia time =24 hours;

3. 18kg/m^2=BMI=30 kg/m^2;

4. American Society of Anesthesiologists (ASA) grade I and II;

Exclusion Criteria:

1. 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;

2. 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);

3. Abnormal laboratory tests during screening:

4. 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;

5. A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;

6. Participated in another clinical trial and received IMP within 30 days prior to screening;

7. Pregnant or lactating women;

8. Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• HSK16149 capsule
Subjects will be given 40mg or 60mg of HSK16149 orally.
• Placebo
Subjects will be given HSK16149 placebo orally.

Locations

Country	Name	City	State
China	Sino-Japanese Friendship Hospital	Beijing
China	Xiangya Third Hospital of Central South University	Changsha	Hunan
China	Chengdu Second People's Hospital	Chengdu	Sichuan
China	Chengdu Third People's Hospital	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Foshan Fuxing Chancheng Hospital	Foshan	Guangdong
China	Guangyuan First People's Hospital	Guangyuan	Sichuan
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Beijing Jishuitan Hospital Guizhou Hospital	Guiyang	Guizhou
China	The First Affiliated Hospital of South China University	Hengyang	Hunan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Lianyungang First People's Hospital	Lianyungang	Jiangsu
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan Central Hospital	Wuhan	Hubei
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Zunyi University Affiliated Hospital	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants received PCA pump, an average of 24 hours after surgery
Secondary	NRS at rest and during exercise	NRS:0 (no pain) to 10 (worst possible pain)	1, 2, 6, 12, 18, and 24 hours after surgery
Secondary	Time of first rescue analgesia with morphine after surgery		Within 24 hours after surgery
Secondary	Incidence of adverse reactions associated with morphine		Within 24 hours after surgery
Secondary	The frequency of rescue analgesia with morphine		Within 24 hours after surgery
Secondary	The total number of PCA presses and the number of effective PCA presses		Within 24 hours after surgery
Secondary	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)	Within 24 hours after surgery
Secondary	Subjects analgesic satisfaction score	Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)	Within 24 hours after surgery
Secondary	Investigators analgesic satisfaction score	Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)	Within 24 hours after surgery
Secondary	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.	From enrollment to 72 hours after surgery