HSK16149 for Perioperative Analgesia in Orthopedic Surgery

NCT ID: NCT06007066

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2023-07-05

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Preoperative administration of HSK16149 40mg

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

Group Type: EXPERIMENTAL

HSK16149 capsule

Intervention Type: DRUG

Subjects will be given 40mg or 60mg of HSK16149 orally.

Preoperative administration of HSK16149 60mg

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

Group Type: EXPERIMENTAL

HSK16149 capsule

Intervention Type: DRUG

Subjects will be given 40mg or 60mg of HSK16149 orally.

Preoperative and postoperative administration of HSK16149 40mg

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

Group Type: EXPERIMENTAL

HSK16149 capsule

Intervention Type: DRUG

Subjects will be given 40mg or 60mg of HSK16149 orally.

Preoperative and postoperative administration of HSK16149 60mg

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

Group Type: EXPERIMENTAL

HSK16149 capsule

Intervention Type: DRUG

Subjects will be given 40mg or 60mg of HSK16149 orally.

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be given HSK16149 placebo orally.

Interventions

HSK16149 capsule

Subjects will be given 40mg or 60mg of HSK16149 orally.

Intervention Type: DRUG

Placebo

Subjects will be given HSK16149 placebo orally.

Intervention Type: DRUG

Other Intervention Names

HSK16149; HSK16149 placebo

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dongguan People's Hospital

Dongguan, Guangdong, China

Foshan Fuxing Chancheng Hospital

Foshan, Guangdong, 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

Zunyi University Affiliated Hospital

Zunyi, Guizhou, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

People's Hospital of Wuhan University

Wuhan, Hubei, China

Wuhan Central Hospital

Wuhan, Hubei, China

Xiangya Third Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of South China University

Hengyang, Hunan, China

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, 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

Guangyuan First People's Hospital

Guangyuan, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Sino-Japanese Friendship Hospital

Beijing, , China

Countries

China

Other Identifiers

HSK16149-204

Identifier Type: -

Identifier Source: org_study_id